BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2874063 · Received December 14, 2012

    Report

    Report Number
    3004209178-2012-11852
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    August 30, 2012
    Report Date
    November 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8840, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4)

    Additional Manufacturer Narrative · 1

    CATHETER: MODEL: 8709, SERIAL#: (B)(4), IMPLANTED: 2004 (B)(6), EXPLANTED: 2012 (B)(6); CATHETER MODEL: 8578, SERIAL# UNKNOWN, IMPLANTED: UNK, EXPLANTED: UNK. (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

    ANALYSIS OF THE PUMP NOTED DURING DISPENSE AND INFUSION TESTING, THE PUMP DISPLAYED ODD GRAPHING WITH INCONSISTENT ACCURACY. IT WAS FOUND THAT THE PUMP TUBE HAD MIGRATED TO THE INLET SIDE OF THE PUMP HEAD. THE TUBE HAD BECOME DISCOLORED, DEFORMED AND HARDENED. TWO HOLES IN THE TUBE WERE FOUND, WHICH WERE BELIEVED TO HAVE OCCURRED MOSTLY DUE TO A COMBINATION OF MECHANICAL AND CHEMICAL STRESSES THAT MAY HAVE CONTRIBUTED TO THE CHANGE IN THE CROSS SECTION OF THE TUBE. IT WAS ALSO BELIEVED THAT A CATHETER OCCLUSION COULD HAVE CONTRIBUTED TO THE PUMP TUBE PERFORMANCE. NO FURTHER ANALYSIS OF THE PUMP TUBE WAS PERFORMED. PUMPHEAD MATERIAL DEGRADATION, DEFORMED PUMP TUBE, AND PUMP MOTOR GEAR TRAIN ANOMALY CORROSION AND-OR WEAR AND-OR LUBRICATION WERE ALSO NOTED. ANALYSIS OF THE CATHETER SEGMENT NOTED IT HAD TO BE CUT IN TWO BECAUSE THE CATHETER WAS OCCLUDED WITH DRIED MATERIAL. LABORATORY TECHNICIANS WERE ABLE TO BREAK LOOSE AND INTERNALLY DECONTAMINATE THE SEGMENT. THE DISTAL END OF THIS SEGMENT HAD BEEN PINCHED TO THE POINT OF BREAKING. THIS COULD HAVE LEAD TO AN OCCLUSION AND CONTRIBUTED TO THE PUMP TUBE PERFORMANCE INSIDE OF THE PUMP. THE CATHETER/CATHETER BODY HAD A COMPRESSED AREA DUE TO PATIENT ANATOMY AND POSSIBLY CAUSED AN OCCLUSION. ANALYSIS OF WHAT WAS BELIEVED TO BE A SUTURELESS CONNECTOR (SC) PROXIMAL REVISION KIT FOUND NO SIGNIFICANT ANOMALIES WITH THIS SEGMENT OF CATHETER. A NON-SIGNIFICANT INDENT WAS FOUND IN THE SEAL, WHICH DID NOT AFFECT INFUSION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECOVERED UNEVENTFULLY AND WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    MULTIPLE MOTOR STALL AND MOTOR STALL RECOVERIES WERE REPORTED. IT WAS STATED THAT "SEVERAL MOTOR STALLS OVER SEVERAL DAYS FOR SHORT TIME PERIODS" HAD BEEN NOTED IN THE PUMP EVENT LOGS. PATIENT HAD NO SYMPTOMS AT THE TIME AND THE PUMP WAS NOT STALLED ON THE DATE OF THIS REPORT. MAGNETS/ENVIRONMENTAL CAUSES HAD BEEN RULED OUT; "STALLS DIDN'T ALWAYS OCCUR AT WORK PLACE". THE NEXT DAY, IT WAS REPORTED THAT AN ALARM WAS HEARD AND ALSO CONFIRMED BY TELEMETRY AS CRITICAL DUE TO MOTOR STALL AND IT WAS INTERMITTENT; STALL OCCURRED AT 02:44 AND ENDED AT 02:53. WITH MULTIPLE SHORT MOTOR STALLS FOR AWHILE, PER REPORTER PATIENT WAS NOW SHOWING "SOME SYMPTOMS OF UNDERDOSE". THE PUMP WAS REPLACED LATER AND IT WAS NOTED THAT IT WAS SINCE (B)(6) 2012 THAT THE HEALTHCARE PROVIDER (HCP)/ PATIENT REPORTED MOTOR STALLS AND "POTENTIAL BOLUS OF MEDS". THE PUMP WAS REPLACED BECAUSE OF "PREMATURE MOTOR STALLS, THEREFORE, INTERRUPTED THERAPY". A CATHETER "BREAK/TEAR/HOLE" WAS FURTHER INDICATED. BOTH THE PUMP AND CATHETER WERE REPLACED; PATIENT SUSTAINED NO INJURY. DRUGS DELIVERED VIA THE DEVICE WERE FENTANYL 0.501 MG, 16.738 MG/DAY; CLONIDINE 0.0601 MG 2.0086 MG/DAY; MARCAINE 301 MG 10,043 MG/DAY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT, DURING EXPLANT, A PIECE OF THE PATIENT'S CATHETER WAS LEFT IN HIM BECAUSE IT WASN'T CONNECTED ANYMORE. IT WAS STATED THAT THE PATIENT HAD ALSO EXPERIENCED WITHDRAWAL SYMPTOMS WHEN HIS PUMP STARTED FAILING.

    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 00048 YR Required Intervention