BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2140561 · Received June 15, 2011

    Report

    Report Number
    9616066-2011-00313
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE INVESTIGATION IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    RECEIVED REPORT THAT THE IV SET HAS FLATTENED PIECE OF TUBING THAT IS SLOWING DOWN THE IV FLOW. THE FLATTENED PIECE IS LOCATED AT THE SHORT ADAPTOR PIECE BETWEEN THE MANIFOLD AND THE STOPCOCK. THE SHORT ADAPTOR PIECE WILL BE RETURNED AS THE REST OF THE SET IS STILL ON THE PATIENT. THERE WAS NO PATIENT HARM REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 10382963 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ALARIS PUMP MODULE: S/N UNKNOWN| ALARIS PC UNIT: S/N UNKNOWN