BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3900220 · Received June 18, 2014

    Report

    Report Number
    9616066-2014-00575
    Event Type
    Death
    Date Received
    June 18, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 28, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 06/18/2014. INTERNAL FILE NO: (B)(4). THIS REPORT WAS FILED BY THE MANUFACTURER. UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED TUBING SPLIT OR RUPTURED BECAUSE THE SET HAS BEEN DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE TUBING "SPLIT OR RUPTURED" AT THE SILICONE SEGMENT INSIDE THE PUMP DURING A RESUSCITATION ATTEMPT. THE PATIENT DID NOT SURVIVE THE EVENT. IT IS NOT KNOWN WHETHER OR NOT THE TUBING RUPTURE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEMISE, HOWEVER, THE NURSE REPORTED THAT THE PHYSICIAN HAD NOT EXPECTED THE PATIENT TO SURVIVE. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358924 ALARIS PUMP MODULE ADMINISTRATION SET INFUSION SET FPA CAREFUSION CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death ALARIS PUMP MODULE| ALARIS PCU: SN UNK