BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2810216 · Received October 31, 2012

    Report

    Report Number
    3004209178-2012-09753
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    October 5, 2012
    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
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (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

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

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS OF THE PUMP FOUND MOTOR GEAR TRAIN ANOMALY. THE ANOMALY WAS CORROSION AND OR WEAR AND OR LUBRICATION. GEAR 1 INSPECTION FOUND SIGNIFICANT RESIDUE ON LOWER SHAFT. MOTOR ASSEMBLY INSPECTION FOUND SIGNIFICANT JEWEL LUBRICATION ANOMALY. GEAR WHEEL 3 INSPECTION FOUND SLIGHT CORROSION ON THE SURFACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HIS PUMP REPLACED BECAUSE THE DOCTOR THOUGHT THE PUMP WAS NOT WORKING CORRECTLY. THE PRINT REPORT FROM THE PUMP INDICATED THAT MULTIPLE MOTOR STALLS WITH "TUBE SET" MESSAGES OCCURRED. NO "RECOVERY" MESSAGE WAS SEEN AFTER THE LAST MOTOR STALL. A LOW RESERVOIR ALARM OCCURRED ON (B)(6) 2012 AND AN EMPTY RESERVOIR ALARM OCCURRED ON (B)(6) 2012. IT WAS MENTIONED THAT THE DEVICE WAS REPLACED ON (B)(6) 2012 (DATE APPROXIMATE). IT WAS NOTED THAT THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THIS EVENT. THE PHYSICIAN CHANGED THE DRUG IN THE PUMP TO PHYSIOLOGICAL SALINE AS A PRECAUTION. THE DRUG IN THE PUMP PRIOR TO THIS WAS UNKNOWN. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention