BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIMBUS II PLUS

    MDR report key: 18117065 · Received November 11, 2023

    Report

    Report Number
    3011581906-2023-00265
    Event Type
    Malfunction
    Date Received
    November 11, 2023
    Date of Event
    June 15, 2023
    Report Date
    February 9, 2024
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FRN
    UDI-DI
    00817170020161
    PMA / PMN Number
    K153193
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    -THE PUMP WAS RECEIVED ON 1/11/2024 AND WAS TESTED ON 2/11/2024 FOR EVALUATION. SEE CASE # (B)(4) ON SALESFORCE FOR MORE INFORMATION. THE INITIAL COMPLAINT WAS CREATED ON CQ AS COMPLAINT # (B)(4), WHICH WAS CLOSED AS "DEVICE NOT RETURNED". THIS COMPLAINT WAS OPENED IN QOS FOR FURTHER INVESTIGATIONS. THERE WERE SEVERAL COMPLAINTS OPEN IN CQ ON THIS DEVICE, AND THEY WERE MOVED TO QOS FOR EVALUATION, SEE COMPLAINT NUMBERS (B)(4). THERE WAS ONE PREVIOUS QOS COMPLAINT, SEE IT2023N-0699. THE PUMP'S EVENT LOG WAS PULLED AND REVIEWED, HIGHLIGHTING SEVERAL CONSECUTIVE LINES OF CODE WITH THE PHRASE "LOG_EVENT_ON" IN A ROW, MEANING THAT THE PUMP POWERED OFF ON IT'S OWN AND NEEDED TO BE TURNED BACK ON, AS SEEN BELOW: "EVENT 0: LOG_EVENT_ON TIME: 13:42:10 SOFTWARE_VERSION: 213 REASON: LOG_ON_CAUSE_ONOFF EVENTBYTES: 00 42 10 00 D5 13 2B 65 EVENT 1: LOG_EVENT_ON TIME: 165:165:165 SOFTWARE_VERSION: 213 REASON: LOG_ON_CAUSE_ONOFF EVENTBYTES: 00 FF FF 00 D5 FF 2B FD EVENT 2: LOG_EVENT_ON TIME: 165:165:165 SOFTWARE_VERSION: 213 REASON: LOG_ON_CAUSE_ONOFF EVENTBYTES: 00 FF FF 00 D5 FF 2B FD EVENT 3: LOG_EVENT_MESSAGE TIME: 165:50:56 INVALID BOLUS KEY PRESSED: 0 INVALID OTHER KEY PRESSED: 1 EVENTBYTES: 09 50 56 00 01 00 80 30 EVENT 4: LOG_EVENT_OFF TIME: 165:50:56 RMP: 0 REASON: LOG_OFF_CAUSE_SHUT EVENTBYTES: 01 50 56 00 00 00 2E D5 EVENT 5: LOG_EVENT_ON TIME: 165:165:165 SOFTWARE_VERSION: 213 REASON: LOG_ON_CAUSE_ONOFF EVENTBYTES: 00 FF FF 00 D5 FF 2B FD EVENT 6: LOG_EVENT_ON TIME: 09:28:22 SOFTWARE_VERSION: 213 REASON: LOG_ON_CAUSE_ONOFF EVENTBYTES: 00 28 22 00 D5 09 2B 53 EVENT 7: LOG_EVENT_ON TIME: 165:165:165 SOFTWARE_VERSION: 213 REASON: LOG_ON_CAUSE_ONOFF EVENTBYTES: 00 FF FF 00 D5 FF 2B FD EVENT 8: LOG_EVENT_ON TIME: 165:165:165 SOFTWARE_VERSION: 213 REASON: LOG_ON_CAUSE_ONOFF EVENTBYTES: 00 FF FF 00 D5 FF 2B FD EVENT 9: UNDEFINED EVENT EVENTBYTES: FF FF FF FF FF FF FF FF " THESE ABRUPT POWER OFFS CAN CAUSE THE PUMP'S EVENT LOG TO BE COMPLETELY WIPED, AND WHEN THE PATIENT RE POWERS THE PUMP ON IT DOES NOT REMEMBER THE PRIOR INFUSION AND ONLY SHOWS "NEW INFUSION" WHEN POWERED ON. THE PUMP'S EVENT LOG THAT WAS PULLED WILL BE ATTACHED TO THE COMPLAINT. IT WAS ALSO NOTED THAT THE MIDDLE PLASTIC HOOK AROUND THE METAL BAR WAS BROKEN, AN IMAGE WILL BE ATTACHED. REPORTED ISSUE FOUND, CAPAS #IT2023-15 AND # IT2023-19 AND OPENED ON THESE COMPLAINT TYPES FOR POWER/BATTERY AND PUMP HOUSING MODULE RESPECTIVELY. PUMP WILL BE PUSHED TO CAPA FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. THIS PUMP PASSED ALL PREVIOUS TESTS. COMPLAINT DATA WAS REVIEWED, THERE ARE NO PREVIOUS COMPLAINTS ON THIS DEVICE. DEVICE RETURN REQUESTED. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    ON (B)(6) 2023 CINDY CAMPBELL, EMPLOYEE OF INTUVIE, RECEIVED A CALL FROM L.B., PATIENT OF FRED HUTCHINSON CANCER CENTER, WHO STATED THAT THEIR PUMP WAS POWERED OFF (ABUPT POWER OFF ON ITS OWN). HUSBAND STATES SCREEN WAS COMPLETELY BLANK. WE ATTEMPTED POWERING IT BACK UP BUT THE ONLY CHOICE WAS NEW INFUSION. ALL INFUSION PARAMETERS WERE LOST. CINDY HAD HIM POWER THE PUMP BACK OFF, CLAMP THE LINE, AND INSTRUCTED THEM TO GO BACK INTO THE CLINIC TO HAVE THIS PUMP REPLACED. HE UNDERSTOOD AND WILL CALL THE FACILITY FIRST. NO OTHER DETAILS GIVEN. INFUSION TOOK PLACE AT HOME. PATIENT INVOLVED. NO PATIENT WAS HARMED. ON (B)(6) 2023 INFUTRONIX RECEIVED A REPORT THAT A PUMP POWERED OFF ON ITS OWN WITHOUT WARNING, CAUSING LOSS OF INFUSION PARAMETERS. THE INFUSION CANNOT RESUME WITHOUT CAUSING DELAY IN TREATMENT. REQUESTED DEVICE TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234482 NIMBUS II PLUS AMBULATORY INFUSION PUMP FRN INFUTRONIX, LLC NIMBUS II PLUS 2206213120 00817170020161

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female