BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBINATION SET 102", ANTI-SIPHON

    MDR report key: 1781591 · Received August 3, 2010

    Report

    Report Number
    6000001-2010-02228
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 7, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FRN
    PMA / PMN Number
    K880733
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS AVAILABLE AND HAS BEEN RECEIVED AND EVALUATED BY BAXTER. EVALUATION: THE REPORTED CONDITION OF DIFFICULT TO CONNECT CONDITION WAS NOT CONFIRMED OR DUPLICATED; THEREFORE AN ASSIGNABLE CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED. ADDITIONAL INFORMATION: BATCH REVIEW WAS CONDUCTED WITH NO ABNORMALITY OBSERVED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED WHEN THE RECOVERY ROOM NURSE ATTEMPTED TO ATTACH BAXTER SET 2L3509 TO BBRAUN SET US1320, THE BAXTER SET "BACKED OFF" THE BBRAUN SET AND THE NURSE WAS UNABLE TO CONNECT. NO PATIENT INJURY OR MEDICAL INTERVENTION OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMBINATION SET 102", ANTI-SIPHON PUMP, INFUSION FRN BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1