BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3130533 · Received May 24, 2013

    Report

    Report Number
    3004209178-2013-08196
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    June 8, 2017
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1570-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL PUMP ANALYSIS REVEALED AN OVERINFUSION WITH UNDETERMINED ROOT CAUSE. NON-DESTRUCTIVE ANALYSIS HAD BEEN PERFORMED. TWO GRAPHS DISPLAYED AN OVER INFUSION. ALL TESTING AND GRAPHS AFTER THE FIRST TWO DID NOT SHOW ANY OVER INFUSION ISSUES.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS PUMP WAS SUBJECTED TO OVER-INFUSION (OI) CAPA TESTING. NO FURTHER OI CAPA TESTING IS REQUIRED PER THE CAPA TEAM. THE RETURN PRODUCT ANALYSIS (RPA) FINISHED OUT THE DESTRUCTIVE ANALYSIS. NO NEW/ADDITIONAL ANOMALIES FOUND DURING DESTRUCTIVE ANALYSIS. ANALYSIS IS COMPLETE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    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

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PATIENT WAS BROUGHT BACK IN TO CHECK PUMP FOR VOLUME ACCURACY. THE ACTUAL RESIDUAL VOLUME WAS LESS THAN THE EXPECTED RESIDUAL VOLUME. ARV: 36.5, ERV: 37.5. ONE PHYSICIAN BELIEVED THE PREVIOUS VOLUME DISCREPANCY WAS CAUSED BY A PARTIAL POCKET FILL BUT ANOTHER PHYSICIAN THOUGHT THAT THIS WAS NOT LIKELY AS THE PATIENT WAS VERY "SKINNY." CALLER STATES THAT PATIENT WAS UNHAPPY AND WANTED THE PUMP REPLACED.

    Description of Event or Problem · 1

    A VOLUME DISCREPANCY WAS REPORTED DURING A REFILL. THE ACTUAL RESIDUAL VOLUME WAS LESS THAT 1 ML AND THE EXPECTED RESIDUAL VOLUME WAS 8.6 ML. THE PUMP WAS REFILLED AND THE PATIENT WAS BEING MONITORED AT THAT TIME. IT WAS NOTED THAT ABOUT SIX WEEKS PRIOR TO THIS REPORT, THE PATIENT REPORTED THEIR TONE WAS GETTING WORSE AND A 15% DRUG INCREASE WAS GIVEN WHICH THE PATIENT REPORTED ¿HELPED¿. THE PATIENT WAS GIVEN ANOTHER 15% INCREASE AT THE REFILL. IT WAS LATER REPORTED THE PATIENT SHOWED SIGNS OF OVERDOSE. IT WAS CONCLUDED ¿THAT WITH AN ALMOST EMPTY PUMP AND TWO INCREASES THE PATIENT HAD AN OVERDOSE WITH A COMPLETELY FILLED PUMP¿. PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) TWO DAYS AFTER REFILL AND THE MEDICATION DOSE WAS DECREASED. PATIENT WAS POSSIBLY ADMITTED FOR OBSERVATION. THE PUMP WAS BEING USED TO DELIVER LIORESAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PUMP WAS REPLACED DUE TO POSSIBLE OVERINFUSION. THE PUMP ¿DUMPED MEDICATION¿ AND THE PATIENT WENT INTO OVERDOSE. THE DEVICE SYSTEM WAS USED TO DELIVER GABLOFEN 2000MCG/ML, 224MCG/DAY.

    Description of Event or Problem · 1

    IT WAS BELIEVED THAT THE PATIENT WAS DOING FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED VIA A HEALTHCARE PROVIDER. IT WAS INDICATED THAT THE PATIENT¿S WEIGHT AT THE TIME OF THE EVENT WAS (B)(6) POUNDS.

    Description of Event or Problem · 1

    THE PATIENT OUTCOME WAS NO INJURY/RECOVERED WITHOUT SEQUELA. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231021 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R