Medical Product Safety Network

$447.50 / year

The Medical Product Safety Network (MedSun) is an adverse event reporting program launched by the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH).

Complexity

The Medical Product Safety Network dataset involves the reporting of problems with medical products from a network of approximately 300 hospitals, nursing homes and home health facilities around the United States.
MedSun sites work collaboratively with the FDA to assist in detecting, understanding, and sharing information concerning the safety of medical products. MedSun utilizes a secure, online system for reporting problems with the use of medical devices. MedSun plays a critical role in FDA’s postmarket surveillance efforts.

The primary goal for MedSun is to work collaboratively with the clinical community to identify, understand, and solve problems with the use of medical devices.
The Safe Medical Devices Act (SMDA) defines ‘user facilities’ as hospitals, nursing homes, and outpatient treatment and diagnostic centers. They are required to report medical device problems that result in serious illness, injury, or death. MedSun participants are also highly encouraged to voluntarily report problems with devices, such as ‘close-calls,’ potential for harm, and other safety concerns. By monitoring reports about problems and concerns before a more serious event occurs, FDA, manufacturers, and clinicians work together proactively to prevent serious injuries and death.

Date Created

2002

Last Modified

2020-06-30

Version

2020-06-30

Update Frequency

Daily

Temporal Coverage

2006-03-24 to 2020-06-30

Spatial Coverage

United States

Source

John Snow Labs; U.S. Food and Drug Administration (FDA);

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

Medical Product Safety, Adverse Event Reporting Program, MedSun, MD Safety, MD Reporting

Other Titles

MedSun Adverse Events Reports, MD Medical Product Safety Network, Medical Devices Safety Network

NameDescriptionTypeConstraints
Device_BrandThe brand of medical devicestring-
Device_ManufacturerDevice manufacturer namestring-
Device_TypeThe type of medical devicestring-
Device_ProblemProblem associated with the devicestring-
Date_ReportThe Date reportdaterequired : 1
Event_DescriptionThe Event descriptionstring-
Device BrandDevice ManufacturerDevice TypeDevice ProblemDate ReportEvent Description
LigaSureCovidien LPELECTROSURGICAL CUTTING COAGULATION ACCESSORIESNot applicable2020-07-08The LigaSure™ Blunt Tip Laparoscopic Sealer/Divider LF1837 gave an error after being plugged into the machine. The staff did not documented the error message. The same LF1837 was tried on a different machine giving the same undocumented error. A second LigaSure device was opened and worked as expected during the surgical procedure. The manufacturer provided tracking # and product return packaging to obtain the defective device. UF send the defective device to the manufacturer on July 8th of 2020.
ECHELON ENDOPATHETHICON ENDO-SURGERY LLCSTAPLE IMPLANTABLEPotential for patient harm2020-07-08Stapler would not fire load.
MicroClave Clear ChemoLockICU MEDICAL INC.Closed antineoplastic and hazardous drug reconstitution and transfer systemPotential for patient harm2020-07-07The RN connected a chemotherapy line to a patient - and line was flushed manually. RN tightened all connections and the line was double checked prior to starting chemotherapy. Immediately upon starting the chemotherapy - the patient reported feeling moisture. There was a leak of the IV MicroClave clear with ChemoLock connector.
Vessel sealerINTUITIVE SURGICAL INC.Vessel SealerPotential for patient harm2020-07-07Defective device- broke during use. Became stuck.
ICU MedicalICU Medical IncIV tubing FLUID TRANSFERPotential for patient harm2020-07-02Bag Spike was having trace amounts of TPN leak and cause a build up around the top of tubing. This is a flexible tubing that we spike with our existing IV tubing to allow administration through 2 lines. The tubing is soft and could potentially stretch which may have led to this issue.
ARROWTELEFLEX INCORPORATEDCatheter intravascular therapeutic long-term greater than 30 daysNot applicable2020-07-02Before a PICC insertion - the nurse trimmed the catheter to a measurement of 43 cm. During the process - the nurse pulled the sensor back a little to prevent damaging the former one during the setup of the catheter. After the catheter was trimmed - the nurse had trouble advancing the sensor getting stuck inside the catheter. The nurse decided to use another PICC kit and restart the process.
Spectrum IQBAXTER INTERNATIONAL INC.Infusion safety management softwarePotential for patient harm2020-07-01Pt was running a 24 hour bag of sodium chloride 0.9 % 500 mL with Doxorubicin 19.8 mg - Etoposide 98.5 mg - vincristine 0.8 mg chemo at 20.8 mL/h. Bag was hung on [date redacted] @ 1403. Bag finished early on [date redacted] @ 1145. Chemo pharmacy was notified. Pump states 51 mL remaining in bag. New pump was used when chemo bag was changed and old pump was sent to biomed. No harm to the patient.
XPER Hemodynamic Monitoring SystemPHILIPS MEDICAL SYSTEMSMonitor Physiological Patient (without Arrhythmia Detection Or Alarms)Potential for patient harm2020-07-01There was an equipment-related issue during procedure in that the Xper hemodynamic monitoring system would not start and patient had to be moved to another room to complete the procedure. (No injury resulted as a result of delay.) Biomedical Engineer (Biomed) follow up: Unable to connect XPER on Workstation. Systemwide down in Cath Lab and OR #. Biomed confirmed the problem on the boot up screen indication - Xper can not establish database connection and RCP/IP connection. Contacted manufacturer and facility information technology department to get the problem solved. Manufacturer follow up: Customer reports when trying to log into the application it does not provide a login screen. Troubleshooting Action: Log onto datacenter the logs report that a scan test was performed disconnecting the data center service from the SQL database. Repair Action: Tech restarted the service and validated in the logs that the application was communicating correctly. The customer was able to log into the application and proceed with the case = there is no need for further action. Suggestion: Please ensure Data Center Services are restarted upon completion of scan test.
Wolf Laparoscopic Grasping ForcepsRichard Wolf GmbHForceps General & Plastic SurgeryPotential for patient harm2020-07-01Screw had fallen out of grasper during laparoscopic procedure. Grasper no longer works and was removed from patient. Screw was also removed from patient. No patient harm.
AlarisCAREFUSION 303 INC.IV administration tubingPotential for patient harm2020-07-01Tubing set crack and leak ====================== Manufacturer response for Tubing - (brand not provided) (per site reporter) ====================== Visual inspection found a lateral crack in the female Luer wall on the opposite end of the injection gate. No signs of excessive torque were observed on the female Luer. A leak was seen from the crack during functional testing. The report of tubing set crack and leak was confirmed. The source of the lead was due to cracked female Luer component. The root cause of the crack was a result of internal stress created in the Luer during manufacturing process. The manufacturing team has implemented process improvement to prevent future occurrences. The reported event will continue to be monitored through our tracking and trending processes.