BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN PUMP 6000 CMS

    MDR report key: 15680584 · Received October 26, 2022

    Report

    Report Number
    MW5112903
    Event Type
    Malfunction
    Date Received
    October 26, 2022
    Date of Event
    September 16, 2022
    Report Date
    September 16, 2022
    Manufacturer
    MOOG COSTA RICA, SRL
    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 COMMUNICATION FROM (B)(6) HOME HEALTH RN, WHO REPORTED THAT THE PT'S PUMP HAS BEEN GIVING HER HIGH UP PRESSURE ALARMS AND DOWN OCCLUSION ALARMS DURING THE PT'S INFUSION ON (B)(6) 2022. THE HOME HEALTH RN HAS FLUSHED THE LINE, CHANGED TUBING, AND IS STILL GETTING THE ALARMS. THE HOME HEALTH RN REPORTS THAT SHE IS ABLE TO INFUSE THE PATIENT AT THE MOMENT BUT WOULD LIKE A NEW PUMP SENT OUT NEW PUL1LJ BEING SENT TO PT. PUL1LJ USED TO INFUSE GAMUNEX AT ABOVE DOSE. NO FURTHER INFORMATION WAS PROVIDED. PRODUCT DID NOT CONTRIBUTE TO PATIENT OR CLINICAL INJURY. ACTUAL DEVICE IS AVAILABLE FOR INVESTIGATION. THERE WAS A BACKUP DEVICE AVAILABLE TO SWITCH TO. LOT PUMP NUMBER: 254076 PUMP DUE DATE: 1/12/2023 INDICATION: CHRONIC INFLAMMATORY DEMYELINATING POLYNEURITIS. REPORTED TO (B)(6) BY: HEALTH PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2867865 CURLIN PUMP 6000 CMS PUMP, INFUSION FRN MOOG COSTA RICA, SRL 254076

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male GAMUNEX| TUBING