BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP CURLIN 6000CMS

    MDR report key: 23498695 · Received November 7, 2025

    Report

    Report Number
    MW5178652
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Report Date
    November 1, 2025
    Manufacturer
    ZEVEX, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PT REPORTED PUMP MALFUNCTION AND THAT HOME HEALTH RN ALREADY STARTED THE INFUSION VIA GRAVITY. PT REPORTS THE PUMP GAVE A 30;1 ERROR CODE: TURN OFF PUMP AND CALL PROVIDER, BAD AUXILIARY BATTERY. PT REPORTED THEY TURNED OFF PUMP, REPLACED BATTERIES, CHECKED TUBING HAD NO KINKS AND STILL DID NOT WORK. PUMP SERIAL NUMBER AND EXPIRATION UNKNOWN. NO FURTHER INFORMATION, DETAILS OR DATES AVAILABLE. PRODUCT LOT AND EXPIRATION UNKNOWN. UNKNOWN IF MD IS AWARE. DOSE/AMOUNT: PRIVIGEN SDV - 35GM. PRIVIGEN SDV INDICATION: ANTIBODY DEFICIENCY WITH NEAR-NORMAL IMMUNOGLOBULINS OR WITH HYPERIMMUNOGLOBULINEMIA. DID PT MISS A DOSE OR HAVE AN INTERRUPTION TO THERAPY? - UNKNOWN; DID ADVERSE EVENT(S) RESULT DUE TO PRODUCT ISSUE? - UNKNOWN; DID PHARMACY REPLACE DEVICE? - YES; IS DEVICE ASSOCIATED WITH EVENT AVAILABLE FOR RETURN? - UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187131 PUMP CURLIN 6000CMS PUMP, INFUSION FRN ZEVEX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female PRIVIGEN SDV.