BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2974480 · Received February 22, 2013

    Report

    Report Number
    3004209178-2013-02990
    Event Type
    Injury
    Date Received
    February 22, 2013
    Report Date
    January 29, 2013
    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
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF CATHETER MODEL 8709SC SEGMENTS 2 AND 3 NOTED THAT NO CATHETER ANCHOR WAS RETURNED WITH THE EXPLANTED CATHETER. AREAS OF TWISTING WERE OBSERVED ON BOTH SEGMENTS 2 AND 3, WITH THE GREATEST AMOUNT OF TWISTING OBSERVED WHERE THE DISTAL END OF SEGMENT 2 MET THE PROXIMAL END OF SEGMENT 3. IT WAS THOUGHT THAT THE TWISTING WAS SO SIGNIFICANT IN THIS AREA THAT THE CATHETER LIKELY OCCLUDED AT THIS POINT AND THEN BROKE, AND MAY HAVE AFFECTED INFUSION. IT WAS NOTED IT WAS ALSO POSSIBLE THAT THE CATHETER BROKE EITHER DURING OR AFTER EXPLANT. ANALYSIS OF CATHETER MODEL 8596SC SEGMENTS 1 AND 2 NOTED NO STRAIN RELIEF SHROUDS FOR THE PIN CONNECTOR WERE RETURNED. NO SIGNIFICANT ANOMALY WAS FOUND. A NON-SIGNIFICANT INDENT WAS OBSERVED IN THE SEAL MATERIAL DOWN IN THE CUP OF THE SC CONNECTOR. THE MAJORITY OF THE INDENT WAS NOT LOCATED IN THE SEAL MATERIAL. TWISTING WAS FOUND IN THE THICKER PROXIMAL CATHETER PORTION OF SEGMENT 2. THE PROXIMAL CATHETER MATERIAL DID NOT TWIST AS READILY AS THE SMALLER DIAMETER DISTAL PORTION OF CATHETER; THEREFORE, IT WAS UNKNOWN IF THE TWISTING OF THE 8596SC PORTION HAD AN EFFECT ON THE FLOW OF FLUID THROUGH ITS INNER LUMEN.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, LOT# 0205091191, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER: PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE VOLUME DISCREPANCIES ASSOCIATED WITH CATHETER ISSUES AND MULTIPLE FLIPPED PUMP EVENTS. IT WAS INITIALLY REPORTED THAT SINCE IMPLANTED, THERE WERE VOLUME DISCREPANCIES AT EACH REFILL. ON THE (B)(6) 2012 REFILL, THE EXPECTED RESIDUAL VOLUME (ERV) WAS 2.5ML AND THE ACTUAL RESIDUAL VOLUME (ARV) ASPIRATED WAS 18ML. AT THE (B)(6) 2012 REFILL THE ERV WAS 2.6ML AND THE ARV WAS 13ML. ON (B)(6) 2012 THE ERV WAS 4.4ML AND THE ARV WAS 18ML. AT THAT TIME AT THE (B)(6) 2012 REFILL, THE PUMP HAD BEEN FOUND TO HAVE FLIPPED OVER AND WAS TURNED BACK BY THE HEALTHCARE PROVIDER (HCP). AT THE FOLLOWING REFILL ON (B)(6) 2012 THE VOLUME DISCREPANCIES CONTINUED WITH A ERV OF 0.8ML AND AN ARV OF 20ML. ON (B)(6) 2013 THE ERV WAS 6.8ML AND THE ARV WAS 20ML. AT THAT TIME OF REFILL ON (B)(6) 2013 A ROTOR TEST WAS PERFORMED WITH A NORMAL RESULT, HOWEVER THE HCP WAS UNABLE TO ASPIRATE THE CATHETER ACCESS PORT (CAP) THEREFORE A DYE TEST WAS NOT CONTINUED. A REVISION WAS THEN PLANNED. IT WAS LATER REPORTED THAT A REVISION TOOK PLACE AND UPON OPENING THE PUMP SITE, THE PUMP SEGMENT WAS FOUND TO BE "VERY TWISTED." THERE WAS NO POUCH AROUND THE PUMP, IT WAS NOT ANCHORED AND THE PUMP HAD FLIPPED OVER AGAIN. THE DECISION WAS MADE TO CHANGE THE ENTIRE CATHETER AT THAT TIME. THE PUMP WAS DISCONNECTED AND DROPLETS OF MEDICATION WERE OBSERVED INDICATING GOOD FUNCTIONING OF THE PUMP. THE PUMP WAS INSERTED INTO A MESH POUCH AND ANCHORED. THE PUMP WAS EMPTIED AND WAS FILLED WITH MEDICATION. AT THE TIME OF REVISION THE PUMP WAS REFILLED, AT WHICH TIME THE ERV WAS 7.5ML AND THE ARV WITHDRAWN WAS 20ML. AT THE COMPLETION OF REVISION, THE PATIENT HAD THE EXISTING PUMP ANCHORED INTO PLACE AND A COMPLETELY NEW CATHETER. THE DRUG BEING DELIVERED AT THE TIME WAS FENTANYL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78090 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention