BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOOG CURLIN 1.2 MICRO IV TUBING SET 340-4128

    MDR report key: 1902910 · Received November 12, 2010

    Report

    Report Number
    MW5018216
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 12, 2010
    Manufacturer
    MOOG MEDICAL DEVICES
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT IS ON HOME TPN IV INFUSION VIA CURLIN 4000 AMBULATORY PUMP. THE IV TUBING -PRODUCT # 340-4128- HAS BEEN CAUSING AIR-IN-LINE ALARMS FREQUENTLY. THIS PROBLEM IS SPECIFIC TO LOT # CF 1018802, AND CRF 10155003. PATIENT REPORTED CONSISTENT ALARMS NIGHTLY, REQUIRING REPRIME OF TUBING TO GET RID OF EXCESS AIR. PATIENT ALSO EXPERIENCED AIR REAPPEARING IN TUBING SOON AFTER AIR WAS REMOVED AND INFUSION WAS RESUMED. PATIENT SWITCHED TO OTHER LOT # -D100315 AND D100304- AND PROBLEM DID NOT OCCUR WITH THESE LOTS. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: TPN HOME INFUSION. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED?: YES. EVENT REAPPEARED AFTER REINTRODUCTION?: #1 YES, #2 YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOOG CURLIN 1.2 MICRO IV TUBING SET 340-4128 CURLIN CMN 4000 AMBULATORY PUMP FPA MOOG MEDICAL DEVICES CF1018802
    2 MOOG CURLIN 1.2 MICRO IV TUBING SET 340-4128 CURLIN CMN 4000 AMBULATORY PUMP FPA MOOG MEDICAL DEVICES CRF 10155003

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR