BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 12255500 · Received July 30, 2021

    Report

    Report Number
    3004209178-2021-11703
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    July 13, 2021
    Report Date
    July 30, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, FOREIGN) REGARDING A PATIENT WHO WAS RECEIVING KETAMINE AND HYD ROMORPHONE VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT WHEN THE PUMP WAS REFILLED AT 11 AM ON (B)(6) 2021, THE HEALTHCARE PROFESSIONAL (HCP) MISTAKENLY PUT THE WRONG MEDICATION IN THE PUMP. THE PUMP SHOULD HAVE CONTAINED HYDROMORPHONE 3.8 MG/ML AT 3.1435 MG/DAY AND BUPIVACAINE 6.8 MG/ML AT 5.625 MG/DAY, BUT INSTEAD THEY PUT IN A MIX OF KETAMINE AND HYDROMORPHONE (CONCENTRATIONS UNKNOWN). AS OF 4:30 PM ON (B)(6) 2021, THE HCP WAS GOING TO CHANGE OUT THE MEDICATION AND REVIEW OPTIONS WITH THE PHYSICIAN ON IF THEY SHOULD ALLOW THE DRUG TO RUN ITS COURSE OR TRY TO LOCATE A CATHETER ACCESS PORT (CAP) KIT. IT WAS NOTED THAT THE HCP DID NOT HAVE A CAP KIT [READILY] AVAILABLE. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS/COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1149475 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1