BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3908459 · Received July 2, 2014

    Report

    Report Number
    3004209178-2014-12400
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 20, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0497-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP (SN (B)(4)) FOUND A GEAR TRAIN ANOMALY OF CORROSION AND/OR WEAR AND/OR LUBRICATION AND THE STALL WAS DUE TO GEAR WHEEL 3. ANALYSIS OF THE CATHETER (UNKNOWN SN) FOUND THE SC CONNECTOR HAD CORING/TEAR/CUTS IN THE SEAL THAT MET LEAK CRITERIA PER NDHF1162-113599.

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE NO LONGER APPLIES TO THIS EVENT. CONCLUSION CODE APPLIES TO THE PUMP AND APPLIES TO THE CATHETER.

    Additional Manufacturer Narrative · 1

    ANALYSIS ALSO NOTED THAT WITH VISUAL INSPECTION OF THE PUMP MINIMAL NEEDLE PUNCTURES WERE FOUND BUT THERE WAS EVIDENCE OF NEEDLE SKID IN THE METAL RING THAT SURROUNDS SEPTUM AND A NEEDLE SKID THAT WENT ACROSS THE SEPTUM MATERIAL. AS THE PUMP WAS ALREADY DESTRUCTIVELY ANALYZED, MODIFIED SEPTUM TESTING DONE. THE PUMP FLUID PATH INCLUDING THE FILL SEPTUM WAS NOT DESTRUCTIVELY ANALYZED. THE PUMP COULD NOT BE SUBMERGED UNDER WATER, SO THE PRESSURE MONITOR TEST DID SHOW A STEADY RESERVOIR PRESSURE OF ABOUT 18.5 PSI. THE 30 PSI SEPTUM TEST WAS MODIFIED AS WELL. THE TECHNICIAN WAS ABLE TO PUT A LARGE "BEED" OF WATER ON THE SEPTUM AND WATCHED FOR A SLOW LEAK AIR BUBBLE TO OCCUR. IF A BREACH WAS PRESENT IN THE SEPTUM THE PUMP WOULD NOT BE ABLE TO HOLD PRESSURE. NO BREACH IN THE SEPTUM WAS ENCOUNTERED DURING ANALYSIS. THIS PUMP WAS ALSO ASSOCIATED WITH MANUFACTURER REPORT # 3004209178-2014-04986.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME WITH UNDERDOSE SYMPTOMS TO THE EMERGENCY UNIT. ACCORDING TO A PUMP INTERROGATION, A MOTOR STALL OCCURRED ON (B)(6) 2014 AT 21:11. THE PUMP WAS REPLACED. DURING THE REPLACEMENT SURGERY NO CEREBROSPINAL FLUID (CSF) BACKFLOW FROM THE CATHETER WAS OBSERVED; HOWEVER, THEY DID NOT CHANGE THE CATHETER. THE PUMP WAS BEING USED TO DELIVER HYDROMORPHONE AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386565 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention