BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3092217 · Received April 19, 2013

    Report

    Report Number
    2016493-2013-00193
    Event Type
    Death
    Date Received
    April 19, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 22, 2013
    Manufacturer
    CARDINAL HEALTH 303, INC.
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, LOGS/DEVICE HAVE NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE LOGS/DEVICE BE RECEIVED FOR EVAL.

    Description of Event or Problem · 1

    THE CUSTOMER REQUESTED A LOG REVIEW BECAUSE OF A PATIENT DEATH. ALTHOUGH NO DEVICE MALFUNCTION IS BEING ALLEGED, THE CUSTOMER WANTS TO KNOW THE PROGRAMMING DETAILS FOR THE TWO INFUSIONS THAT THE PATIENT HAD BEEN RECEIVING, VANCOMYCIN AND SOLUMEDROL. INTENDED PROGRAMMING WAS NOT PROVIDED BUT THE CUSTOMER STATED THAT THE PATIENT HAD RECEIVED VANCOMYCIN PREVIOUSLY AND THAT THE ¿SOLUMEDROL WAS EXPIRED BY ONE DAY¿. ALTHOUGH REQUESTED, THE DEVICES HAVE NOT BEEN RETURNED FOR INVESTIGATION. THE CUSTOMER IS UNCERTAIN WHETHER THE DEVICES WILL BE RETURNED AND STATED THAT THE MEDICAL BAGS HAVE BEEN SENT TO THE CORONER. THE CUSTOMER STATED THAT NO FURTHER PATIENT OR EVENT DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169484 ALARIS PUMP MODULE FRN CARDINAL HEALTH 303, INC. 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death THERAPY:| ALARIS PUMP MODULE: SN (B)(4)| THERAPY:| ALARIS PUMP MODULE ADMIN SET: MODEL/LOT UNK| ALARIS PC UNIT: SN (B)(4)