BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POMPE À PERFUSION PLUM 360¿, COMPATIBLE AVEC LE LOGICIEL ICU MEDICAL MEDNET¿

    MDR report key: 17486902 · Received August 9, 2023

    Report

    Report Number
    9615050-2023-00310
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Date of Event
    August 1, 2023
    Report Date
    August 1, 2023
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K161469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S COMPLAINT WAS INVESTIGATED AND TESTING WAS PERFORMED ON THE PUMP. THE LOGS WERE REVIEWED. TIME PERIOD: 21-JUN-2023 TO 25-JUL-2023, SEVEN ENTRIES OF N185 (PEAK PROXIMAL OCCLUSION A NON-DELIVERY) WERE IDENTIFIED ON 25-JULY-2023. THE PROBABLE CAUSE FOR THE IDENTIFIED ERROR CODES COULD NOT BE DETERMINED. ALTHOUGH THE PUMP FAILED VISUAL INSPECTION DUE TO A CRACKED REAR CASE/DOOR ASSEMBLY, THE DEVICE PASSED OCCLUSION TESTING WITHOUT ISSUE. THE PRESSURE DETECTOR WILL BE RECALIBRATED AS A PRECAUTION DURING REPAIR. D9 - DATE RETURNED TO MFG: 14AUG2023.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION WAS UPDATED ON 03OCT2023 TO INCLUDE THE FOLLOWING INFORMATION: IN ADDITION TO THE THE DEVICE PASSING THE OCCLUSION TESTING WITHOUT ISSUE DURING THE COMPLAINT INVESTIGATION, THE INFUSION PUMP DEVICE ALSO PASSED ALL TESTING, INCLUDING A FULL PERFORMANCE VERIFICATION TESTING (PVT) WITHOUT ANY ISSUE. THE DEVICE ALARMED AUDIBLY WHEN EXPECTED DURING OCCLUSION TESTS. THE COMPLAINT COULD NOT BE CONFIRMED THROUGH TESTING OR THROUGH ALARM LOGS REVIEW. NO PROBABLE CAUSE FOR THE CUSTOMER'S REPORTED ISSUE COULD BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 0

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A POMPE À PERFUSION PLUM 360¿, COMPATIBLE AVEC LE LOGICIEL ICU MEDICAL MEDNET¿. THE FOLLOWING ISSUE WAS REPORTED BY THE CUSTOMER: ¿MISSED OCCLUSION¿. THERE WAS NO HUMAN HARM REPORTED AS A RESULT OF THIS EVENT/COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1904393 POMPE À PERFUSION PLUM 360¿, COMPATIBLE AVEC LE LOGICIEL ICU MEDICAL MEDNET¿ PUMP, INFUSION FRN ICU MEDICAL COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown