BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRONO 5 PUMP SYRINGE

    MDR report key: 8595603 · Received May 8, 2019

    Report

    Report Number
    MW5086473
    Event Type
    Malfunction
    Date Received
    May 8, 2019
    Date of Event
    April 24, 2019
    Report Date
    April 24, 2019
    Manufacturer
    INTRA PUMP INFUSION SYSTEMS
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT SPONTANEOUSLY STATED THAT ONE OF HER CRONO 5 PUMPS (UNABLE TO PROVIDE SERIAL NUMBER) WAS SHOWING "ERROR 5" ON THE SCREEN AND SHE WAS UNABLE TO TROUBLESHOOT THE ISSUE. SHE STATED IT OCCURRED DURING A SYRINGE CHANGE SO SHE SWITCHED TO HER BACKUP PUMP AND DID NOT HAVE A LAPSE IN THERAPY. NO SIDE EFFECTS REPORTED. WE ARE SENDING PT A REPLACEMENT PUMP AND SHE WILL SEND BACK THE MALFUNCTIONING PUMP FOR REVIEW. IS THE ACTUAL DEVICE AVAILABLE TO BE RETURNED FOR INVESTIGATION? YES; DID WE (MFR) REPLACE DEVICE? YES. DID THE PT HAVE A BACKUP DEVICE THEY WERE ABLE TO SWITCH TO? YES. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH A PATIENT? YES; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? NO; REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386626 CRONO 5 PUMP SYRINGE PUMP, INFUSION FRN INTRA PUMP INFUSION SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR