BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 5902106 · Received August 24, 2016

    Report

    Report Number
    9616066-2016-01163
    Event Type
    Malfunction
    Date Received
    August 24, 2016
    Report Date
    August 12, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K931173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 100ML FRESENIUS KABI BAG INTRALIPID 20% NDC 0338-0519-58, LOT 10KB2029, EXP 01/2018, THERAPY DATE UNK. ADDITIONAL INFORMATION PROVIDED: DEVICE AVAILABLE FOR EVALUATION? (B)(4). THE CUSTOMER¿S REPORT THAT THE TUBING SPLIT IN HALF WAS CONFIRMED. THE SET WAS RECEIVED SEPARATED BETWEEN THE SILICONE PUMP SEGMENT AND THE LOWER FITMENT. THE RING RETAINER WAS RECEIVED WITH THE SET AND THERE WAS A RING RETAINER INDENTATION OBSERVED AROUND THE END OF THE SILICONE PUMP TUBING WHERE THE SEPARATION OCCURRED. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE SEPARATION. DIMENSIONAL TESTING FOUND THE SILICONE PUMP TUBING TO BE WITHIN SPECIFICATION. THE CAUSE OF THE SEPARATION IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PUMP INDICATED "AIR IN LINE" AND WHEN THE NURSE WENT TO INSPECT AND ADJUST TUBING, THE TUBING SPLIT IN HALF. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551782 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2202-0500

    Patients

    Seq Age Sex Outcome Treatment
    1 56 DA