BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN 6000 PUMP

    MDR report key: 16305546 · Received February 3, 2023

    Report

    Report Number
    MW5114712
    Event Type
    Malfunction
    Date Received
    February 3, 2023
    Report Date
    January 25, 2023
    Manufacturer
    MOOG / ZEVEK, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SPONTANEOUS CALL FROM (B)(6), HOME HEALTH NURSE STATING THAT NEW CURLIN PUMP. SHE STATED THAT PUMP HISSES WITH AIR EACH INFUSION AND SHE UNDERSTANDS REASON FOR IT. THERE WAS OCCLUSION MESSAGE ON PUMP, SO SHE DISCONNECTED ALL THE SUPPLY AND TRY TO CONNECT AGAIN AND BEFORE SHE CAN ATTACH TUBING THE PUMP SENT OUT ERROR MESSAGE DOWN PRESSURE ISSUE WHILE THE PUMP WAS NOT CONNECTED TO ANYTHING. M STATED THAT SHE HAS BEEN USING PUMP FOR A WHILE. AFTER CONNECTING NEW TUBE AND PRIMING IT, SHE WAS ABLE TO CONTINUE THE INFUSION, SERIAL# (B)(4). LOT# NOT AVAILABLE. NO INJURY OR ADVERSE EVENTS REPORTED/ NEW PUMP WILL BE SENT. PUMP USED TO INFUSE GAMUNEX-C INFUSE 30GM {300ML) INTRAVENOUSLY, DAILY FOR 2 DAYS, EVERY 3 WEEKS. INFUSE OVER AT LEAST 4 HOURS. INDICATION: CHRONIC INFLAMMATORY DEMYELINATING POLYNEURITIS. REPORTED TO CVS/CAREMARK BY: HEALTH PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114552 CURLIN 6000 PUMP PUMP, INFUSION FRN MOOG / ZEVEK, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male GAMUNEX- C.