BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP CURLIN 6000CMS

    MDR report key: 17436846 · Received July 31, 2023

    Report

    Report Number
    MW5120440
    Event Type
    Malfunction
    Date Received
    July 31, 2023
    Report Date
    July 18, 2023
    Manufacturer
    MOOG / ZEVEX, 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

    PATIENT'S HHRN CALLED STATING THAT THE NEW PUMP IS NOT WORKING PROPERLY. SHE [NURSE] KEEPS GETTING AN ERROR MESSAGE AND HAD TO RESTART THE PUMP SEVERAL TIMES DURING THE INFUSION YESTERDAY AND TODAY. PATIENT CURRENTLY HAS 2 PUMPS IN HIS POSSESSION. HHRN STATED THE OLD PUMP STILL WORKS FINE, SO THEY ARE USING IT IN THE MEANTIME. ADVISED HHRN OKAY TO USE THE OLD PUMP UNTIL WE CAN GET A REPLACEMENT SENT. NO MORE INFORMATION OR DATES PROVIDED. NO MISSED DOSE OR ADVERSE EVENT REPORTED. DEFECTIVE PUMP ON HAND FOR RETURN TO MANUFACTURER. STRENGTH: GAMUNEX-C 10% SDV(20GM/200ML), GAMUNEX-C 10% SDV[10GM/100ML]. INDICATION: CHRONIC INFLAMMATORY DEMYELINATING POLYNEURITIS. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773300 PUMP CURLIN 6000CMS PUMP, INFUSION FRN MOOG / ZEVEX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male GAMUNEX-C 10% SDV (10GM/100ML)| GAMUNEX-C 10% SDV (20GM/200ML)