BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3790743 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-08527
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 11, 2014
    Report Date
    November 21, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1570-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, LOT # UNKNOWN, PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ANALYSIS IDENTIFIED STALL DUE TO SHAFT-BEARING ON THE GEAR TRAIN OF THE MOTOR. ANALYSIS IDENTIFIED CORROSION ON THE GEAR TRAIN OF THE MOTOR. (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED CATHETER SEGMENT REVEALED THE SUTURELESS CONNECTOR HAD A NON-SIGNIFICANT INDENT IN THE SEAL WHICH DID NOT AFFECT INFUSION. THE LOGS WERE GATHERED FROM THE PUMP AND A MOTOR STALL RECOVERY WAS NOTED IN THE PUMP LOGS. THIS INDICATED THAT DURING THE PUMP¿S LIFE A PAST MOTOR STALL AND MOTOR STALL RECOVERY HAD OCCURRED. BOTH DISPENSE AND INFUSION ACCURACY TESTING DISPLAYED OVERINFUSION. HOWEVER, THE ROOT CAUSE OF THE OVERINFUSION WAS UNDETERMINED.

    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 THE PUMP WAS EXPLANTED. IT WAS NOTED THE PATIENT CAME FOR A REFILL PROCEDURE ON (B)(6) 2014. IT WAS REPORTED THERE WAS A VOLUME DISCREPANCY WHERE THE EXPECTED RESIDUAL VOLUME WAS 4.1ML AND THE ACTUAL RESIDUAL VOLUME WAS 0ML, SO THE RESERVOIR WAS EMPTY AND NOTHING COULD BE ASPIRATED. THE PATIENT STATUS WAS NOTED AS ALIVE WITH NO INJURY. NO PATIENT SYMPTOMS WERE REPORTED. THE PUMP WAS USED TO DELIVER FENTANYL. ADDITIONAL INFORMATION REPORTED THE PUMP DELIVERED HYDROMORPHONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267106 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention