BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADD HIGH-VOLUME ADMINISTRATION SETS

    MDR report key: 2233939 · Received August 26, 2011

    Report

    Report Number
    2183502-2011-00600
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 25, 2011
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FPA
    PMA / PMN Number
    K991599
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND REVALUATED, THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTED THAT DEVICE WAS IN USE WITH PT TO INFUSE PARENTERAL NUTRITION. WHEN THE INFUSION RATE WAS REDUCED TO 100 ML/HR THE INFUSION PUMP GAVE AN OCCLUSION ALARM. ACCORDING TO REPORT, THE DEVICE WAS THEN ATTACHED TO SPARE INFUSION PUMP BUT ALARM OCCURRED AGAIN. PT WAS BROUGHT INTO HOSPITAL CARE TO COMPLETE PARENTERAL NUTRITION INFUSION. NO PERMANENT ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADD HIGH-VOLUME ADMINISTRATION SETS FPA - SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL 21-7081 242X20

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Hospitalization