BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIMBUS II PLUS AMBULATORY INFUSION PUMP

    MDR report key: 16199797 · Received January 18, 2023

    Report

    Report Number
    3011581906-2022-00249
    Event Type
    Injury
    Date Received
    January 18, 2023
    Date of Event
    December 15, 2022
    Report Date
    January 18, 2023
    Manufacturer
    INFUTRONIX, LLC.
    Product Code
    FRN
    UDI-DI
    00817170020086
    PMA / PMN Number
    K153193
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INFUTRONIX IS WAITING FOR THE AFFECTED DEVICE TO BE RETURNED.

    Description of Event or Problem · 0

    A DISTRIBUTOR FOR INFUTRONIX RECEIVED A COMPLAINT FROM A PATIENT WHO REPORTED "SEVERE PAIN" FOLLOWING A SYSTEM ERROR. SYSTEM ERROR WAS DISCOVERED AT APPROX 5AM ON THE MORNING AFTER SURGERY. PATIENT AWOKE IN SEVERE PAIN. PATIENT'S SON DROVE TO CLINIC TO RETRIEVE REPLACEMENT PUMP. HEALTHCARE PROFESSIONAL AT CLINIC ADVISED THE PATIENT TO "DOUBLE THE OXYCODONE AND ADD 1,000 MG TYLENOL". PATIENT WAS BACK ON PAIN PUMP BY 2PM THAT AFTERNOON. INFUSION COMPLETED SUCCESSFULLY. PATIENT IS NOW RECOVERING WELL. DEVICE OPERATOR WAS THE PATIENT. MEDICATION BEING INFUSED WAS ROPIVAXCAINE. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS ZYNO ELECTRIC & MACHINERY LTD, SHANGHAI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068996 NIMBUS II PLUS AMBULATORY INFUSION PUMP AMBULATORY INFUSION PUMP FRN INFUTRONIX, LLC. NIMBUS II PLUS 2202064320 00817170020086

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention METHOCARBAM 750 MG.| NICE COLD WATER MACHINE.| OXYCODONE 5 MG.