BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASSETTE MEDI RESERVOIR

    MDR report key: 12681781 · Received October 21, 2021

    Report

    Report Number
    MW5104854
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    October 17, 2021
    Report Date
    October 17, 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 RECEIVED FROM PATIENT STATING THAT HE IS TRYING TO GET THE AIR OUT AFTER MIXING THE CASSETTE. INSTEAD OF AIR COMING OUT, THE MEDICATION IS COMING OUT FROM THE CASSETTE TO THE SYRINGE. REACHED OUT TO RICHARD, CNSS AND ADVISED IF PATIENT HAS THE CASSETTE IS PLACED CORRECTLY IN THE CUP (DIAGNOSTICALLY) AND BLUE TAP SHOULD FACE UPWARDS. PATIENT SAID IT IS PLACED CORRECTLY AND IT IS THE FIRST TIME WITH THIS ISSUE. THE CASSETTE'S LOT#4152726. ADVISED PATIENT TO PREPARE A NEW MIX. PATIENT SAID HE HAS ENOUGH MEDICATION AND SUPPLIES, AND WILL CALL PHARMACY ON MONDAY TO PLACE THE ORDERS. DID NOT OCCUR WHILE IN USE. NO CLINICAL INJURY. ADVISED PATIENT TO KEEP THE FAULTY CASSETTE. PATIENT WILL CALL PHARMACY TO PLACE MORE CASSETTES. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PT? NO; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY? NO; IS THE ACTUAL CASSETTE AVAILABLE FOR INVESTIGATION? YES; DID WE [MFR] REPLACE THE CASSETTE? PT HAS ENOUGH, HE WILL, PHARMACY TO PLACE MORE TODAY. DID THE PT HAVE ADD'L CASSETTES THEY WERE ABLE TO SWITCH TO? YES. REPORTED TO (B)(6) BY PT/(B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1568012 CASSETTE MEDI RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR FPA 4152726

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR