BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2981192 · Received February 27, 2013

    Report

    Report Number
    3004209178-2013-03120
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED THE PUMP PASSED ALL NON-DESTRUCTIVE TESTING AND NO ANOMALY WAS FOUND. NO ANOMALIES WERE NOTED IN THE PUMP LOGS. NO FURTHER TESTING WAS PERFORMED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RETURNED TO THE HOSPITAL DUE TO A RETURN OF PAIN. WHEN THE PHYSICIAN CHECKED THE RESERVOIR VOLUME OF THE PUMP, IT WAS FOUND THAT THERE WERE 20ML OF DRUG INSTEAD OF THE EXPECTED 11.4ML. THE PUMP LOGS WERE READ, BUT NO MOTOR STALL MESSAGE WAS SEEN. ADDITIONALLY, A DYE TEST WAS PERFORMED AND IT APPEARED THAT THE CATHETER WAS OKAY, AS THERE WERE NO PROBLEMS ASPIRATING OR FILLING THE CATHETER ACCESS PORT. THE PHYSICIAN ATTEMPTED A ROTOR TEST, BUT IT SEEMED THAT THE MOTOR WAS AT A STANDSTILL. ADDITIONAL REQUIRED INTERVENTIONS INCLUDED HOSPITALIZATION, REPROGRAMMING, AND THE USE OF "OS DRUGS." THE REPLACEMENT OF THE PATIENT'S PUMP WAS PLANNED AS WELL. AT THE TIME OF REPORT, THE PATIENT OUTCOME WAS NOTATED AS ALIVE, BUT WITH INJURY. INITIALLY, THE DRUG USED IN THIS SYSTEM WAS MORPHINE, THOUGH AS OF (B)(6), BUPIVACAINE WAS MIXED WITH THE MORPHINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS NOT RECEIVING THERAPY. THE PHYSICIAN TRIED TO ASPIRATE FROM THE CATHETER ACCESS PORT AND "IT WAS IMPOSSIBLE TO DRAIN SOME DRUG." THE PUMP WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83594 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R