BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMETRA II PROGRAMMABLE PUMP

    MDR report key: 17736976 · Received September 13, 2023

    Report

    Report Number
    3010079947-2023-00059
    Event Type
    Malfunction
    Date Received
    September 13, 2023
    Date of Event
    August 24, 2023
    Report Date
    September 13, 2023
    Manufacturer
    ALGORITHM SCIENCES, INC.
    Product Code
    LKK
    UDI-DI
    00810335020228
    PMA / PMN Number
    P080012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD, WHICH INCLUDES VERIFICATION OF ALL STEPS IN THE MANUFACTURING OF THE PUMP, VERIFICATION OF ALL FINAL TESTING PERFORMED BY/ON THE PUMP, VERIFICATION OF STERILIZATION, AND PACKAGING FOR SUBJECT PUMP WAS PERFORMED. THE REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCE'S, ISSUES OR CAPAS ASSOCIATED WITH PUMP FUNCTION. DEVICE WAS NOT RETURNED FOR ADDITIONAL EVALUATION AND INVESTIGATION. AS ADDITIONAL INVESTIGATION WAS NOT PERFORMED ON THE DEVICE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THE ALLEGED ISSUE. SEVERAL ATTEMPTS WERE MADE BY TECHNICAL SOLUTIONS TO RETRIEVE FOLLOW UP INFORMATION RELATED TO THE ISSUE, BUT THESE ATTEMPTS WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MDR WILL BE SENT. INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 0

    REPORTER FROM A PHYSICIAN'S OFFICE CONTACTED TECHNICAL SOLUTIONS REGARDING A PATIENT'S PUMP THAT WAS NOT COMMUNICATING WITH THEIR PROGRAMMER. TECHNICAL SOLUTIONS ASKED THE REPORTER TO POWER-CYCLE THE PROGRAMMER AND REINQUIRE THE PUMP. THE REPORTER STATED THAT AFTER INQUIRING, ERROR CODES 100, 114 AND 115 WERE OBSERVED. THE REPORTER STATED THAT THE PUMP'S BATTERY LEVEL WAS OKAY WHEN IT WAS LAST INQUIRED. TECHNICAL SOLUTIONS ADVISED THE REPORTER THAT A PUMP EXPLANT WAS RECOMMENDED FOR THIS ISSUE. NO ADDITIONAL INFORMATION WAS MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2060941 PROMETRA II PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK ALGORITHM SCIENCES, INC. 13827 20323 00810335020228

    Patients

    Seq Age Sex Outcome Treatment
    1 Female