BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 4853139 · Received June 18, 2015

    Report

    Report Number
    9616066-2015-00798
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Date of Event
    June 9, 2015
    Report Date
    June 10, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    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

    (B)(4)

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED. THE CUSTOMER COMPLAINT OF A BALLOONED PUMP SEGMENT WAS CONFIRMED PER PICTURE RECEIVED BY THE CUSTOMER. IT WAS OBSERVED PER PICTURE RECEIVED THAT THE SILICONE SEGMENT TUBING HAD A BALLOONED BULGE NEAR THE UPPER PORTION OF THE UPPER FITMENT THE ROOT CAUSE FOR THIS EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BALLOONED PUMP SEGMENT. ALTHOUGH REQUESTED; NO ADDITIONAL EVENT INFORMATION PROVIDED. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396308 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2420-0500

    Patients

    Seq Age Sex Outcome Treatment
    1