BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3970714 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-13752
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 9, 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
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8780, 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 ON (B)(6) 2014, THE PATIENT WAS SEEN IN THE CLINIC AND A DECISION WAS MADE TO SWITCH THE DRUG IN THE PUMP FROM DILAUDID TO FENTANYL. THEY PLANNED TO DO THE REMOVING SYSTEM CONTENTS PROCEDURE TO REMOVE THE DILAUDID FROM THE SYSTEM, BUT THEY WERE UNABLE TO ASPIRATE THE CAP (CATHETER ACCESS PORT) OF DRUG DESPITE USING FLUORO, SO THIS WAS NOT DONE. THEY PROGRAMMED A BRIDGE BOLUS TO DELIVER THE DILAUDID AT THE APPROPRIATE DOSING RATE; THE DURATION WAS 108 HOURS. ON (B)(6) 2014, IN THE MORNING, THE PATIENT¿S WIFE CALLED AND STATED THAT THE PATIENT WAS FEELING SOB (SHORT OF BREATH), SWEATY, HIS ABDOMEN WAS HARD, AND HE WAS NOT COMMUNICATING WELL. THE PATIENT¿S WIFE WAS DIRECTED TO TAKE THE PATIENT TO THE ER (EMERGENCY ROOM). IN THE EVENING OF THE SAME DAY, THE PATIENT WENT TO THE ER AND HAD A MEDICAL/CARDIAC WORKUP DONE WHICH WAS NEGATIVE. THE PATIENT WAS DIAGNOSED WITH WITHDRAWAL AND PRESCRIBED ORAL PAIN MEDS. THE PATIENT¿S SYMPTOMS IMPROVED AND HE WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS SCHEDULED TO RETURN TO THE CLINIC FOR EVALUATION. AT THE LAST PUMP REFILL, THE EXPECTED RESERVOIR VOLUME WAS 36.4ML; THE ACTUAL RESERVOIR VOLUME WAS 36.5. AT THE TWO PREVIOUS REFILLS THERE WERE NO VOLUME DISCREPANCIES. IT WAS LATER REPORTED THAT THEY HAD ATTEMPTED THREE TIMES TO ASPIRATE FROM THE CAP. IT WAS NOTED THAT THE PATIENT WAS VERY SENSITIVE TO ALL MEDS. THE PATIENT SHOULD HAVE STARTED TO RECEIVE THE FENTANYL AT 4AM ON (B)(6) 2014. ON (B)(6) 2014, THE PATIENT HAD ADDITIONAL SYMPTOMS OF FEELING HOT/COLD, DIDN¿T WANT TO BE TOUCHED, IRRITABLE, AND WAS HAVING A HARD TIME GETTING WORDS OUT. THE PATIENT WAS ADMITTED FOR THE CARDIAC EVALUATION. AFTER BEING DIAGNOSED WITH THE WITHDRAWAL, THE PATIENT WAS TREATED WITH IV (INTRAVENOUS) AND ORAL DILAUDID WHICH GAVE HIM RELIEF. THE CAUSE OF THE PATIENT¿S SYMPTOMS WAS UNKNOWN. WHEN THE PATIENT RETURNED TO THE CLINIC ON (B)(6) 2014, THE LOGS WERE CHECKED AND THERE WERE NO INTERMITTENT STALLS NOTED. THE ISSUE WAS RESOLVED. IT WAS NOTED THAT THE PATIENT ¿DEVELOPED WITHDRAWAL ¿ PROLONGED ¿ ONCE HE WAS OFF DILAUDID AND ONLY GETTING FENTANYL.¿ THE PATIENT EVENTUALLY IMPROVED AND RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NEVER A BROKEN NEEDLE; THAT NEVER HAPPENED. THERE WAS NO OCCLUSION SUSPECTED; THE NEEDLE WAS REPORTEDLY NOT THE ISSUE; THEY ¿JUST COULD NOT ASPIRATE.¿

    Description of Event or Problem · 1

    WHEN ATTEMPTING TO ASPIRATE FROM THE CAP (CATHETER ACCESS PORT), ¿THEY BROKE 5 NEEDLES.¿ THE PATIENT DID NOT FEEL WELL ON (B)(6) 2014. HE DID NOT GET OUT OF BED UNTIL (B)(6) 2014. THE PATIENT SUFFERED ¿MAJOR WITHDRAWALS¿ FOR 2.5 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446808 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Hospitalization