BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2834615 · Received November 15, 2012

    Report

    Report Number
    3004209178-2012-10345
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO ANOMALIES. THIRTY-FIVE MILLILITERS (ML) OF FLUID WERE ASPIRATED WHEN THE PUMP WAS RECEIVED. THE PUMP PASSED ALL NON-DESTRUCTIVE TESTING. THE PUMP LOGS WERE CLEAN; NO MOTOR STALLS, MOTOR STALL RECOVERIES, OR ERRORS OF ANY KIND WERE FOUND IN THE PUMP LOGS. THE RESERVOIR ACCESS ALLEGATIONS WERE TRIED TO BE REPRODUCED. THIS WAS DONE BY FILLING THE PUMP WITH 40 ML OF WATER THEN ASPIRATING FIVE TIMES, THEN FILLING WITH 20 ML OF WATER AND ASPIRATING 5 TIMES. NO PROBLEMS WITH ASPIRATING OR FILLING WERE ENCOUNTERED. ANALYSIS OF THE RETURNED NEEDLES REVEALED THAT A 22 GAUGE AND A 24 GAUGE NEEDLE WERE RETURNED. THE 24 GAUGE NEEDLE WAS PATENT UPON ARRIVAL. THE 22 GAUGE NEEDLE WAS FOUND TO BE OCCLUDED. THIS OCCLUSION WAS PUSHED OUT OF THE NEEDLE'S CANNULA WITH A CLEAN STYLET. THIS SAMPLE WAS FURTHER ANALYZED AND REPORTED TO BE INORGANIC MATERIAL; SILICONE.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_REFILLKIT_ACC, SERIAL#: UNKNOWN, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-IMPLANT THE NURSE ATTEMPTED TO WITHDRAWAL WATER FROM THE PUMP AND COULD NOT WITHDRAWAL MORE THAN 3 ML. SEVERAL ATTEMPTS WERE MADE AT TROUBLE SHOOTING; HOWEVER, THE PUMP WOULD NOT ASPIRATE. ANOTHER REPORTER STATED THAT THE NURSE WAS ABLE TO ASPIRATE 20 ML OF WATER FROM THE 40 ML RESERVOIR AND THEN IT STOPPED. THE NURSE REMOVED THE NEEDLE AND PUT THE CATHETER ACCESS PORT (CAP) NEEDLE ON AND FLUSHED THE CAP. SHE THEN WENT BACK ATTEMPTING TO ASPIRATE THE PUMP AGAIN USING THE 22 GAUGE REFILL SEPTUM NEEDLE BUT WAS UNABLE TO DO SO. THE NEEDLE WAS TAKEN OUT OF THE PUMP AND WATER WAS PUSHED THOUGH THE NEEDLE WITH LITTLE RESISTANCE. THE NURSE THEN WENT BACK TO THE PUMP AND WAS ABLE TO ASPIRATE THE REMAINING AMOUNT OF STERILE WATER AND FILL SUCCESSFULLY. THE PUMP WAS NEVER IMPLANTED AND WAS NEVER IN CONTACT WITH THE PATIENT. THE PATIENT WAS REPORTED TO BE DOING WELL WITH NO COMPLICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention