BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3133942 · Received May 1, 2013

    Report

    Report Number
    9616066-2013-00298
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Report Date
    April 8, 2013
    Manufacturer
    CAREFUSION COROPORATION
    Product Code
    FPA
    PMA / PMN Number
    K951922
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SET HAS BEEN REC'D AND THE EVALUATION IS PENDING. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULT ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    MATERIALS MGR REPORTED THAT ANESTHESIA REPORTED THE SET SPLIT NEAR ONE OF THE Y SITES DURING A PROCEDURE (SO PRESUMED TO BE DURING AN INFUSION). THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION. NO FURTHER PT OR EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190969 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION COROPORATION 2447-0600 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE: SN UNK| ALARIS PC UNIT: SN UNK