BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2992964 · Received March 7, 2013

    Report

    Report Number
    3004209178-2013-03448
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 8, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_CATH, SERIAL # UNKNOWN, EXPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER; PRODUCT ID 8709, LOT # L80507, IMPLANTED: (B)(6) 2000, EXPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. ANALYSIS OF THE PUMP REVEALED THE PUMP LOGS WERE CLEAN; NO MOTOR STALLS OCCURRED DURING THE PUMP LIFE. DISPENSE TESTING WAS PERFORMED WHICH SHOWED AN ATYPICAL 300 UL/DAY GRAPH, WHICH ALSO INDICATED AN OVER INFUSION. FURTHER DISPENSE ACCURACY TESTING SHOWED THAT THE OVER INFUSION WAS REPEATABLE. AN INFUSION TEST AT THE SAME RATE FOR A LONGER PERIOD OF TIME WAS PERFORMED TO SEE IF A PATTERN EMERGED, AND THE INFUSION TESTING PASSED. IT WAS DISCOVERED THAT THE PUMP TUBE HAD BEEN DISCOLORED AND HARDENED, WITH LOSS OF ELASTICITY. THE PUMP TUBE LEAK TEST PASSED. THE INCONSISTENT DISPENSE GRAPHING AND ACCURACY WAS BELIEVED TO HAVE BEEN CAUSED BY THE CONDITION OF THE DEFORMED PUMP TUBE. A COMBINATION OF MECHANICAL AND CHEMICAL STRESSES MAY HAVE CONTRIBUTED TO THE CHANGE IN THE CROSS SECTION OF THE TUBE. DESTRUCTIVE ANALYSIS OF THE PUMP TUBE WAS NOT PERFORMED TO PRESERVE THE INTEGRITY OF THE COMPONENT SHOULD ADDITIONAL TESTING BE REQUIRED. THE SEGMENT OF MODEL 8709 CATHETER THAT WAS RETURNED WAS BELIEVED TO BE PART OF THE ORIGINAL 8709 CATHETER IMPLANTED. WITH WHAT WAS RETURNED, BOTH ENDS OF THE CATHETER WERE SMOOTH AND COULD HAVE BEEN CUT TO REMOVE AT EXPLANT. THE SHORTER SEGMENT WAS APPROXIMATELY 0.7 CENTIMETERS (CM) IN LENGTH, AND APPEARED TO HAVE BEEN PINCHED, WORN DOWN, OR IN A POSITION THAT WOULD HAVE CAUSED THE DEFORMITY. THE CATHETER BODY WAS DEFORMED IN SHAPE AND-OR ABRASION, BUT THIS DID NOT AFFECT INFUSION. NO SIGNIFICANT ANOMALY WAS FOUND WITH THE CATHETER. NO ANOMALIES WERE FOUND WITH THE RETURNED UNKNOWN MODEL/SERIAL SEGMENT OF CATHETER. THE CATHETER WAS INCOMPLETE; RETURNED IN SEGMENTS, AND HAD ACCEPTABLE TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) AND WAS PROPHYLACTICALLY REPLACED TO AVOID IN-VIVO BATTERY DEPLETION. THE PATIENT DID WELL AFTER SURGERY AND RECOVERED WITHOUT SEQUELA. THEY WERE REPORTED TO BE RECEIVING EFFECTIVE THERAPY AND HAVE NOT HAD ANY ISSUES. THE PUMP WAS USED TO DELIVER HYDROMORPHONE AND BUPIVACAINE. THE RETURNED DEVICES UNDERWENT ROUTINE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97821 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR