BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3833383 · Received May 15, 2014

    Report

    Report Number
    2016493-2014-00248
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    May 1, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS FILED BY THE MANUFACTURER. NO PRODUCT OR EVENT LOGS WERE RETURNED FOR EVALUATION. THE REPORT THAT THE PCU ALARMED FOR BATTERY ERROR AND THEN SHUT DOWN COULD NOT BE CONFIRMED. BECAUSE THE CUSTOMER DID NOT RECORD THE DEVICE SERIAL NUMBER AND NO DEVICE OR DEVICE LOGS WERE RETURNED OR EXPECTED TO BE RETURNED, NO FAILURE INVESTIGATION COULD BE PERFORMED. THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT'S BLOOD PRESSURE DROPPED TO "50" (PRESUMED TO MEAN 50 MMHG SYSTOLIC) WHEN THE PCU SHUT DOWN DURING AN INFUSION OF LEVOPHED. THE CUSTOMER STATED THAT ALTHOUGH THE PCU WAS PLUGGED IN, IT ALARMED FOR BATTERY ERROR AND THEN SHUT DOWN. THE INFUSION WAS RESTARTED ON A DIFFERENT PC UNIT AND THE PATIENT'S BLOOD PRESSURE RETURNED TO BASELINE. THERE WAS NO REPORT OF LASTING PATIENT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289658 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other ALARIS PC UNIT: SN UNK| ALARIS PUMP MODULE ADMIN SET: MODLE/LOT UNK