BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASSETTE MEDI RESERVOIR

    MDR report key: 12681914 · Received October 21, 2021

    Report

    Report Number
    MW5104864
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    October 18, 2021
    Report Date
    October 18, 2021
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS CALL; PATIENT STATED THAT SHE USED CASSETTE LOT #4173641 TODAY AND IT WOULDN'T READ IN EITHER ONE OF HER 2 PUMPS. BOTH PUMPS KEPT BEEPING WITH NO ERROR MESSAGE AFTER PLACING THE CASSETTE IN PATIENT STATED THAT SHE REPLACED THE BATTERY, MADE SURE SHE HAD NO CLAMPING ANYWHERE, AND STILL HAD SAME BEEPING WITH NO ERROR MESSAGE. PATIENT WAS ABLE TO REPLACE THE CASSETTE TO NEW ONE AND IT WORKED IN HER PUMP WITH NO ISSUE. NO INTERRUPTION IN TREATMENT REPORTED. NO SIDE EFFECT REPORTED. PATIENT HAS EXTRA SUPPLIES NO HAND. SHE DOESN'T NEED SHIPMENT AT THIS TIME. BOTH PUMPS ARE WORKING FINE. ONLY CASSETTE PRODUCT COMPLAINT REPORTED. NO OTHER INFO PROVIDED AT THIS TIME. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PT? YES; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY? NO; IS THE ACTUAL CASSETTE AVAILABLE FOR INVESTIGATION?NO; DID WE [MFR] REPLACE THE DEVICE? NO; DID THE PT HAVE ADD'L CASSETTES THEY WERE ABLE TO SWITCH TO? YES; IF YES, WAS THE PT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES; IS THE INFUSION LIFE-SUSTAINING? YES; WHAT IS THE OUTCOME OF THE EVENT? RESOLVED; ONGOING? NO. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1568132 CASSETTE MEDI RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR FPA 4173641

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR