BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2709247 · Received August 8, 2012

    Report

    Report Number
    9616066-2012-00548
    Event Type
    Malfunction
    Date Received
    August 8, 2012
    Report Date
    July 12, 2012
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K894842
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S REPORT OF A SET LEAKING WAS CONFIRMED. THE LEAK WAS NOTED ON THE PVC TUBING TO THE DRIP CHAMBER BLOOD FILTER TOP AND NOT THE PUMPING SEGMENT AS REPORTED BY THE CUSTOMER. VISUAL EXAMINATION NOTED THE PVC TUBING WAS COMPLETELY SEPARATED FROM THE DRIP CHAMBER BLOOD FILTER TOP CAP PORT. VISUAL EXAMINATION UNDER THE MICROSCOPE NOTED THAT BOTH SIDES OF THE PVC TUBING HAD INSUFFICIENT SOLVENT APPLIED AT THE ENGAGEMENT DURING THE MANUFACTURING PROCESS. THERE WAS NO OTHER ANOMALIES OBSERVED WITH THE RETURNED SET DURING INITIAL INSPECTION. FUNCTIONAL TESTING OF THE RETURNED SET WAS DEEMED UNNECESSARY DUE TO THE TUBING SEPARATION FROM THE DRIP CHAMBER TOP CAP PORT. DIMENSIONAL ANALYSIS WAS PERFORMED ON THE PVC TUBING AND IT WAS FOUND TO BE WITHIN SPECIFICATION. THE ROOT CAUSE OF THE CUSTOMER'S LEAK WAS IDENTIFIED AS A MANUFACTURING ISSUE DUE TO INSUFFICIENT SOLVENT BEING APPLIED AT THE JUNCTION OF THE PVC TUBING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A HOLE IN THE PUMP SEGMENT, RESULTING IN A LEAK. NO PT HARM OR MEDICAL INTERVENTION REQUIRED. CUSTOMER STATED THAT NO FURTHER PT OR EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 10015414 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK