BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2921074 · Received January 17, 2013

    Report

    Report Number
    3004209178-2013-00734
    Event Type
    Injury
    Date Received
    January 17, 2013
    Report Date
    December 27, 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
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE PUMP FOUND NO ANOMALY. THE PUMP LOGS INDICATED A COUPLE OF MOTOR STALLS AND RECOVERIES. DISPENSE ACCURACY TESTING PASSED. TWO INFUSION TESTS PERFORMED, ON AT 37 DEGREES C AND ONE AT 43 DEGREES C. BOTH INFUSION TESTS PASSED FOR INFUSION ACCURACY. THE 43 DEGREE TEST RESERVOIR PRESSURE WAS ELEVATED AND DUE TO THE INCREASE IN TESTING TEMPERATURE; 21 DAYS VOLUME INFUSION TEST WAS PERFORMED, VOLUME IN RESERVOIR WAS COMPARED TO VOLUME ON 8840 PRINTOUTS. VOLUME INFUSION TESTING PASSED. DESTRUCTIVE ANALYSIS WAS DONE. MOTOR WIRE FEED THROUGH MI HAS SOME CORROSION PRESENT AND A SLIGHTLY LOWER RESISTANCE OF 1 MEG, SPECIFICATION WAS 10 MEG. ALSO NOTED THAT RESIDUE WAS PRESENT ON THE PUMP HEAD AND PUMP TUBE SURFACE. THE PUMP TUBE ALSO WAS SLIGHTLY DEFORMED, DISCOLORED WITH A SLIGHT LOSS OF ELASTICITY. PUMP PASSED RETURNED PRODUCT ANALYSIS TESTING AND THE COMPLAINT OF VOLUME DISCREPANCY WAS NOT CONFIRMED IN THE LAB.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: PATIENT WAS SEEN POST MRI AND THE PUMP WAS CHECKED. PATIENT REPORTED THAT THE NEW PUMP HAD HAD NO PROBLEMS AND HE HAD NOT EXPERIENCED ANY EPISODES OF WITHDRAWAL OR ANY OF THE SYMPTOMS; WAS VERY PLEASED AND HAD GOOD PAIN CONTROL

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS AT A REFILL ON THE DATE OF THIS REPORT AND HE WAS EXPERIENCING SIGNS AND SYMPTOMS OF WITHDRAWAL. THE PUMP WAS SUPPOSED TO HAVE 6 CC OF MEDICATION, BUT ONLY 1 CC WAS WITHDRAWN. THE PUMP WAS THEN FILLED WITH 20 CC OF MEDICATION. IT WAS ALSO REPORTED THAT THE PUMP WAS NOT METERING THE MEDICATION CORRECTLY. THE PUMP WAS "RUNNING TOO FAST" THAT THE PATIENT WAS OUT OF MEDICATION ABOUT 10 OR 12 DAYS EARLY ON HIS CYCLES. THE PATIENT GOT "VIOLENTLY ILL" AND "NEARLY DIE" IN (B)(6) 2012. HE WAS "VOMITING SO BAD THAT HE WAS VOMITING HIS INSIDES." HE "TORE A LEFT HEART VALVE UP." IT WAS LATER REPORTED THAT THE PUMP WAS REPLACED ON (B)(6) 2013. THE EVENT LOGS REVEALED A MOTOR STALL OCCURRED ON (B)(6) 2012 AND IT WAS RECOVERED AN HOUR LATER. ANOTHER MOTOR STALL OCCURRED ON (B)(6) 2013 AND RECOVERED 23 MINUTES LATER. MOTOR STALLS OCCURRED DUE TO MAGNETIC RESONANCE IMAGING. THE PATIENT OUTCOME WAS NOTED AS RECOVERED WITHOUT SEQUELAE. THE PUMP WAS BEING USED TO DELIVER HYDROMORPHONE, BUPIVACAINE AND PRIALT. REFER TO MANUFACTURER REPORT # 3004209178-2012-09772.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING A 5CC MEDICATION VOLUME DISCREPANCY AT EACH OF HIS REFILLS. THE PATIENT HAD WITHDRAWAL SYMPTOMS STARING FROM FOUR DAYS BEFORE EACH OF HIS REFILL DATES. HIS UNDERDOSE AND WITHDRAWAL SYMPTOMS INCLUDE: ACHING, SWEATING, NERVOUSNESS, NAUSEA, WEAKNESS, A STRANGE ODOR OF URINE AND STOOLS, A BAD TASTE IN HIS MOUTH, INCREASED HEART RATE, AND "NOT FEELING WELL." IT WAS REPORTED THAT HIS PHYSICIAN TOLD HIM THAT HE HAD BEEN "SWEATING THE DRUG OUT" DURING HIS DAILY, TWO-HOUR, HOT BATHS. THE PHYSICIAN INSTRUCTED THE PATIENT TO TAKE SHOWERS INSTEAD OF BATHS AND HE ALSO MOVED HIS REFILL DATE A WEEK EARLIER TO REASSESS FOR WITHDRAWAL. AT THE TIME OF REPORT, THERE WAS NO PATIENT INJURY OR ADVERSE EVENT. THE DRUGS USED IN THIS SYSTEM WERE DILAUDID AND PRIALT. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CLINICIAN PROGRAMMER STATED THE PUMP SHOULD HAVE HAD 2.8 ML IN THE RESERVOIR; THE HEALTH CARE PROVIDER (HCP) WITHDREW A COUPLE DROPS. IT WAS REPORTED THERE IS AN OBVIOUS VOLUME DISCREPANCY THAT HAD BEEN OCCURRING AT EACH REFILL SINCE (B)(6) 2012, IT WAS NOTED THIS OCCURRED WITH THE SIX PREVIOUS REFILLS. IT WAS REPORTED THAT EACH TIME THERE WAS LESS FLUID IN THE PUMP THAN EXPECTED. THE PATIENT ALSO EXPERIENCED A WEIGHT LOSS OF TEN POUNDS. IT WAS REPORTED THE RESERVOIR ALARM WAS SET TO 6 ML. A REFERRAL TO THE SURGEON FOR A PUMP REPLACEMENT WAS REPORTED TO HAVE BEEN SUBMITTED. IT WAS REPORTED THE PATIENT HAD NOT HAD ANY HOT BATHS SINCE THE LAST REFILL IN ORDER TO RULE OUT THAT AS A POSSIBLE CAUSE. IT WAS NOTED THERE WERE NO SYMPTOMS OF OVERDOSE AT ANY TIME BETWEEN REFILLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26048 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention