BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+/A+3 (V 11.X & 13.X)

    MDR report key: 15003373 · Received July 13, 2022

    Report

    Report Number
    9615050-2022-00142
    Event Type
    Malfunction
    Date Received
    July 13, 2022
    Date of Event
    June 1, 2022
    Report Date
    June 17, 2022
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED. AN INVESTIGATION IS PENDING.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS IN GOOD GENERAL CONDITION. THE EVENT/ALARM LOGS WERE DOWNLOADED AND SAVED ON FILE. LOGS ATTACHED TO SR# (B)(6). THE LAST ENTRIES IN THE LOGS WERE ON THE (B)(6)2022 AT 7.40. AT 07.40 THE DEVICE IS PROGRAMMED AS FOLLOWS: (B)(6) 2022 07:40 LINEA A: DURATA: 00:56 (B)(6) 2022 07:40 LINEA A: VELOCITÀ:250, VDI:235,0 THIS PROGRAM COMPLETES SUCCESSFULLY WITHOUT ISSUE 56 MIN LATER AT 08.36. (B)(6) 2022 08:36 N161 VDI LINEA A COMPLETE THEN AT 08.41, THE DEVICE VTBI IS CHANGED TO ADD ANOTHER 30ML. (B)(6) 2022 08:41 LINEA A: DURATA: 00:07 (B)(6) 2022 08:41 LINEA A: VELOCITÀ:250, VDI:30,0 THIS PROGRAM COMPLETES SUCCESSFULLY WITHOUT ISSUE 7 MIN LATER AT 08.48. (B)(6) 2022 08:48 ARRESTO INFUSIONE: A, VOLUME INFUSO=265,0 (B)(6) 2022 08:48 PROGRAMMA LINEA A: COMPLETATO THIS SHOWS THAT THE DEVICE PERFORMED AS PROGRAMMED AND DELIVERED A TOTAL OF 265ML AS EXPECTED. THE DEVICE COMPLETED FULL PERFORMANCE VERIFICATION TESTING (PVT) WITHOUT ISSUE. THE CUSTOMER¿S PROTOCOL WAS PROGRAMMED AND COMPLETED SUCCESSFULLY DELIVERING A TOTAL OF 263.5ML. THE COMPLAINT IS NOT CONFIRMED, AND NO PROBABLE CAUSE COULD BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, ON AN UNKNOWN DATE, THE PLUM A+ PUMP PRESENTS A MISMATCH BETWEEN THE LIQUID LIMITS SET AND THE LIQUIDS ADMINISTERED: THE INFUSION SET EMPTIES ABNORMALLY. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1702128 PLUM A+/A+3 (V 11.X & 13.X) PUMP, INFUSION FRN ICU MEDICAL COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNSPECIFIED LIQUID, UNK MFR.