BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 4258089 · Received August 29, 2014

    Report

    Report Number
    2016493-2014-00422
    Event Type
    Injury
    Date Received
    August 29, 2014
    Date of Event
    July 7, 2014
    Report Date
    August 11, 2014
    Manufacturer
    CARDINAL HEALTH 303, INC.
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE DEVICE HAS NOT BEEN RECEIVED FOR INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED WITH EVALUATION RESULTS SHOULD THE DEVICE BE RETURNED. THE DEVICES HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A BAG OF 5FU (FLUOROURACIL) WAS EMPTY SOONER THAN EXPECTED. A BAG WITH 2615 MG 5FU/1052.3 ML NS WAS HUNG AS A SECONDARY AT 2034 TO INFUSE AT 45.7 ML/HR, BUT THE 5FU AND THE PRIMARY SALINE WERE BOTH EMPTY AT 0330. THE PATIENT WAS ASYMPTOMATIC WITH STABLE VITAL SIGNS IMMEDIATELY AFTER THE EVENT. TWO DAYS LATER HE BECAME LETHARGIC, WEAK ON THE LEFT SIDE, WITH CONFUSION, DIMINISHED RECALL ABILITY, NAUSEA AND VOMITING. CT SCAN OF THE HEAD AND MRI WERE DONE. THE NEURO SYMPTOMS LATER RESOLVED AND THE PATIENT WAS DISCHARGED HOME WITH NO LONG TERM ADVERSE EFFECTS. NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527748 ALARIS PUMP MODULE INFUSION PUMP FRN CARDINAL HEALTH 303, INC. 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention ALARIS PUMP MODULE SN (B)(4)| ALARIS PCU SN (B)(4)| ALARIS TUBING SETS, MODELS/LOTS UNK