BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BATTERY ALKA AA-+

    MDR report key: 14085365 · Received April 11, 2022

    Report

    Report Number
    MW5108921
    Event Type
    Injury
    Date Received
    April 11, 2022
    Date of Event
    April 3, 2022
    Report Date
    April 7, 2022
    Manufacturer
    UNK
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT ADVISED HE IS CURRENTLY INPATIENT AND HAS BEEN IN THE HOSPITAL ALL WEEK AS OF (B)(6) 2022, DUE TO GAINING 20 LBS IN 3 DAYS AND HE WAS HAVING TROUBLE BREATHING. PER PATIENT HE IS ALSO SCHEDULED FOR AN MRI SINCE THERE HAS BEEN SOME IMPAIRED SPEECH. PER PATIENT HE BELIEVES HE MAY BE DISCHARGED EITHER SUNDAY ((B)(6) 2022) OR MONDAY ((B)(6) 2022). PATIENT ALSO MENTIONED THAT HE BELIEVES HE RECEIVED A BATCH OF DEFECTIVE BATTERIES, HE CHANGED THEM MONDAY AND BY THURSDAY THEY WERE DRAINED. PER PATIENT THIS HAPPENED IN BOTH HIS PUMPS FROM THE SAME BATCH AND DOES NOT USUALLY HAPPEN. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PT? UNK; IS THE PRODUCT AVAILABLE FOR INVESTIGATION? UNK; DID WE [MFR] REPLACE THE BATTERIES? UNK; DID THE PT HAVE BACKUP BATTERIES THEY WERE ABLE TO SWITCH TO? UNK. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901566 BATTERY ALKA AA-+ PUMP, INFUSION FRN UNK
    901567 BATTERY ALKA AA-+ PUMP, INFUSION FRN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Hospitalization VELETRI