BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP CURLIN 60000 CMS

    MDR report key: 16043064 · Received December 22, 2022

    Report

    Report Number
    MW5113956
    Event Type
    Malfunction
    Date Received
    December 22, 2022
    Report Date
    December 5, 2022
    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 PT'S HOME HEALTH RN (B)(6) WHO WAS AT PT'S HOME TO INFUSE. (B)(6) WAS GETTING "ALARM SYSTEM TIMEOUT ERROR" ON PT'S CURLIN PUMP. LOOKED AT USER MANUAL. ADVISED KATHY TO TRY AND CHANGE BATTERIES WHICH SHE DID BUT WAS STILL GETTING ERROR. INFORMED (B)(6) SHE WILL HAVE TO INFUSE VIA GRAVITY USING GRAVITY TUBING AND DIAL A FLOW. INDICATION: COMMON VARIABLE IMMUNODEFICIENCY, UNSPECIFIED. 1. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PATIENT? YES. 2. DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? IF YES, WAS ANY MEDICAL INTERVENTION PROVIDED? NO PT IS STILL ABLE TO GET INFUSION. 3. IS THE ACTUAL DEVICE AVAILABLE FOR INVESTIGATION? PT WILL BE SENDING PUMP BACK. 4. DID WE REPLACE THE DEVICE? YES THERE IS AN OPEN ORDER FOR PUMP MAINTENANCE WHICH WE WILL BE SHIPPING TO. 5. DID THE PATIENT HAVE A BACKUP DEVICE THEY WERE ABLE TO SWITCH TO? NO, RN INFUSING VIA GRAVITY TUBING. REPORTED TO (B)(6) BY: HEALTH PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2261449 PUMP CURLIN 60000 CMS PUMP, INFUSION FRN MOOG / ZEVEK, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male TUBING.