BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 7541441 · Received May 24, 2018

    Report

    Report Number
    2016493-2018-00445
    Event Type
    Injury
    Date Received
    May 24, 2018
    Date of Event
    January 21, 2018
    Report Date
    May 3, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A PATIENT'S AMINOPHYLLINE DRIP INFUSED FASTER THAN THE PRESCRIBED DOSE, AND THE PATIENT DEVELOPED IATROGENIC THEOPHYLLINE TOXICITY WITH PROLONGED QTC, AND NAUSEA AND VOMITING. THE PATIENT ALSO HAD A NSTEMI (NON ST ELEVATED MYOCARDIAL INFARCTION) FROM DEMAND ISCHEMIA AND UNDERWENT A STRESS TEST WHICH SHOWED MODERATE SIZED INFARCTION OF APEX BUT NO ISCHEMIA." THE PATIENT WAS PROVIDED SUPPORTIVE CARE WITH RESOLUTION OF HER SYMPTOMS.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PATIENT'S AMINOPHYLLINE DRIP INFUSED FASTER THAN THE PRESCRIBED DOSE, AND THE PATIENT DEVELOPED IATROGENIC THEOPHYLLINE TOXICITY WITH PROLONGED QTC, AND NAUSEA AND VOMITING. THE PATIENT WAS PROVIDED SUPPORTIVE CARE WITH RESOLUTION OF HER SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385651 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention PRI TUBING,8015, THERAPY DATE UNK| THERAPY DATE (B)(6) 2018| PRI TUBING,8015, THERAPY DATE UNK