BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4140291 · Received October 3, 2014

    Report

    Report Number
    3004209178-2014-18284
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    August 7, 2014
    Report Date
    September 8, 2014
    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
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: UNKNOWN PROG, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: CATHETER. PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED TO CLARIFY THE PROGRAMMING ERROR. IT WAS REPORTED THAT THE PATIENT WENT IN FOR A PUMP REFILL ON (B)(6) 2014 AND HAD INCREASED PAIN. THEY WANTED AN INCREASE OF PUMP DOSAGE. PER THE PHYSICIAN, THE PATIENT WAS REFILLED, THE DOSAGE WAS INCREASED AND THEY SET UP THE PERSONAL THERAPY MANAGER (PTM) FOR BOLUSES, 2 ACTIVATIONS ALLOWED PER DAY WITH A LOCKOUT OF 8 HOURS. THE PHYSICIAN ALSO GAVE THE PATIENT A PRESCRIPTION FOR ORAL MORPHINE 30MG TABLETS TO TAKE FOUR TIMES A DAY. THE CONCENTRATION OF HYDROMORPHONE CHANGED FROM 8MG/ML TO 15MG/ML. IN THE SAME ENCOUNTER DATE (B)(6) 2014 IT WAS ALSO NOTED THAT THE PATIENT REPORTED ADEQUATE PAIN RELIEF AND INCREASED FUNCTION AS A RESULT OF THE MEDICATION PRESCRIBED. THE PATIENT HAD DENIED ANY ADVERSE SIDE EFFECTS AS A RESULT OF TAKING THE MEDICATION. THE PATIENT WAS EXPECTED TO RETURN TO THE OFFICE IN 2 MONTHS FOR RE-ASSESSMENT OF PAIN. THE REFILL DATE AT MAX ACTIVATION WAS SET FOR (B)(6) 2014. ON (B)(6) 2014 WHEN THE PHYSICIAN WAS ORDERING MEDICATION FOR NEXT REFILL THEY NOTICED THAT THE CONCENTRATION OF HYDROMORPHONE WAS CHANGED FROM 8MG/ML TO 15MG/ML BUT NOT CHANGED PER TELEMETRY (ON PHYSICIAN PROGRAMMER). THE CONCENTRATION AND DOSAGE OF BUPIVACAINE HAD NOT CHANGED FROM 15MG/ML. IT WAS ALSO NOTED THAT THEY HAD NOT PROGRAMMED A BRIDGE BOLUS. DUE TO NOT MAKING THE CHANGES IT APPEARED THAT THE PATIENT HAD 8MG/ML WITH CONTINUOUS RATE OF 5.9638MG/DAY WITH PATIENT ACTIVATED (PA) DOSAGES AT 0.2MG BUT IN REALITY THE PATIENT WAS ACTUALLY GETTING CONTINUOUS RATE OF 11.182MG/DAY WITH PA AT 0.375MG/DAY. THE TOTAL DOSE IF ALL BOLUSES USED WOULD BE 11.9MG/DAY OF HYDROMORPHONE WHEN IT WAS PROGRAMMED AS 6.3472MG/DAY. ON THE NEXT REFILL DATE THEY WERE GOING TO PROGRAM THE HYDROMORPHONE CORRECTLY AND WHEN PROMPTED TO DO BRIDGE BOLUS, THEY SELECT "NO BOLUS." ON (B)(6) 2014 THE HEALTHCARE PROVIDER (HCP) LEFT MESSAGE FOR THE PATIENT TO CHECK ON THEM. THE PATIENT WAS SEEN ON (B)(6)(B)(6) 2014 FOR THEIR PUMP REFILL. THE PUMP WAS REFILLED. THE PATIENT'S PUMP WAS INTERROGATED AND THE LOGS REVEALED THAT THE PATIENT WAS USING THE PTM PA BOLUSES 0-2X/DAY. EVEN THOUGH THE PATIENT WAS ACTUALLY GETTING TWICE THE AMOUNT OF HYDROMORPHONE AS PROGRAMMED THE PATIENT REPORTED THEY HAD "DONE WELL." THE PAIN HAD BEEN BETTER AND THE PATIENT DID NOT HAVE ANY ADVERSE EFFECTS OF "DROWSINESS, ETC." THE PHYSICIAN DECIDED IT WAS OKAY TO LEAVE THE PATIENT AT THE CONTINUOUS DOSE OF 11.182MG/DAY OF HYDROMORPHONE WITH PA DOSE OF 0.375MG AND TOTAL DOSE OF 12.62MG/DAY, AS HE ALSO ORDERED TO CHANGE TO LOCKOUT TO 5 HOURS AND ALLOW 4 ACTIVATIONS A DAY. THE PATIENT HAD BEEN TAKING THE ORAL MORPHINE, BUT THE PHYSICIAN DECREASED THE DOSE FROM 30MG TO 15MG FOUR TIMES A DAY. THE PATIENT REPORTED THEY HAD PAIN IN THE SHOULDERS, LOW BACK, WRIST, KNEES, FEET, HANDS AND RIGHT ELBOW. THE PATIENT REPORTED THEIR PAIN AS A "6' ON A SCALE OF 1 TO 10 USING THE VISUAL ANALOG SCALE (VAS). THE PATIENT'S VITAL SIGNS WERE "TEMPERATURE 98.0 F, BLOOD PRESSURE (BP) 114/73, PULSE 74 AND RESPIRATION 20." A URINE DRUG SCREEN WAS PERFORMED BUT RESULTS WERE PENDING. THE NEXT REFILL DATE WAS 2014-11-11. THE PROGRAMMING ERROR WAS CORRECTED ON (B)(6) 2014. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DRUG CONCENTRATION WAS CHANGED AT THE (B)(6) REFILL FROM HYDROMORPHONE 8 MILLIGRAMS (MG) PER MILLILITER (ML) TO 15 MG/ML BUT THE CHANGE WAS NOT ENTERED INTO THE PHYSICIAN PROGRAMMER AND A BRIDGE BOLUS WAS NOT PROGRAMMED. THE PATIENT HAD NOT REPORTED ANY ADVERSE EFFECT FROM THE CHANGE. REPORTEDLY, THE PATIENT THEN HAD BEEN GETTING 11.18 MG/DAY. PROGRAMMING WAS DISCUSSED ON HOW TO CORRECT AT THE PATIENT¿S NEXT REFILL ¿NEXT WEEK.¿ THIS DEVICE SYSTEM DELIVERED HYDROMORPHONE AND BUPIVACAINE. ADDITIONAL INFORMATION WAS REQUESTED TO VERIFY IF THE PATIENT EXPERIENCED ANY SYMPTOMS, THE CURRENT STATUS OF THE PATIENT AND RESOLUTION TO THIS ISSUE; HOWEVER, THE INFORMATION WAS NOT AVAILABLE AT THE TIME OF THE REPORT. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619014 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR