BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRONO SUPER PID PUMP

    MDR report key: 12672308 · Received October 20, 2021

    Report

    Report Number
    MW5104799
    Event Type
    Injury
    Date Received
    October 20, 2021
    Date of Event
    June 1, 2021
    Report Date
    June 4, 2021
    Manufacturer
    INTRA PUMP INFUSION SYSTEMS / CANE' S.P.A.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT'S MOTHER ADVISED OF THE PUMP STOPPING AND STARTING AND ONLY PUMPING FOR A TOTAL OF 2 HOURS AND 45 MINUTES INSTEAD OF THE USUAL 12 HOURS, RESULTING IN THE PATIENT ONLY GETTING 2 HOURS AND 45 MINS WORTH OF THE MEDICATION AND LEAVING THE REST UNFINISHED. NO MISSED DOSE BUT PT ONLY GOT PARTIAL DOSE; NO ADVERSE EVENT REPORTED; UNKNOWN IF DEVICE AVAILABLE FOR RETURN; UNK EXPIRATION. NO FURTHER INFORMATION KNOWN. PUMP USED TO INFUSE DEFEROXAMINE AT ABOVE DOSE/FREQUENCY. SERIAL NUMBER # (B)(4), EXP: 05/12/2022, INDICATION: HEMOCHROMATOSIS DUE TO REPEATED RED BLOOD CELL TRANSFUSION. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PT? YES; WAS ANY MEDICAL INTERVENTION PROVIDED? NO; IS THE ACTUAL DEVICE AVAILABLE FOR INVESTIGATION? YES; DID WE [MFR] REPLACE THE DEVICE? YES; DID THE PT HAVE A BACKUP DEVICE 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
    1566915 CRONO SUPER PID PUMP PUMP, INFUSION FRN INTRA PUMP INFUSION SYSTEMS / CANE' S.P.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR