BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3565892 · Received January 9, 2014

    Report

    Report Number
    3004209178-2014-00426
    Event Type
    Injury
    Date Received
    January 9, 2014
    Date of Event
    December 16, 2013
    Report Date
    December 21, 2013
    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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION/EVALUATION SUMMARY: ANALYSIS REVEALED A ¿GEAR TRAIN ANOMALY ¿ CORROSION AND/OR WEAR AND/OR LUBRICATION¿ DURING ANALYSIS OF THE PUMP RESIDUE AND SHAFT WEAR WERE SEEN ON THE LOWER SHAFTS OF GEAR 1 AND 2. SOME RESIDUE WAS ALSO FOUND ON THE JEWEL WHERE THE LOWER SHAFTS OF GEAR 1 AND 2 INSERT INTO THE BOTTOM BRIDGE ASSEMBLY. THE STALL WAS NOTED TO BE DUE TO SHAFT BEARING.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8590-1, LOT# N180847, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. (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

    IT WAS REPORTED A CONFIRMED MOTOR STALL NOTED IN EVENT LOGS WITH NO MOTOR STALL RECOVERY RECORDED. PER THE REPORTER, THE PATIENT FELL ON MONDAY (B)(6) 2013 AND BEGAN TO FEEL SICK WEDNESDAY (B)(6) 2013. THE PATIENT WAS AT THE ER (EMERGENCY ROOM) NOW. THE REPORTER READ THE LOGS AND THERE WAS A MOTOR STALL THAT OCCURRED ON (B)(6) 2013 AT 19:33 AND A TUBE SET MESSAGE THAT OCCURRED (B)(6) 2013. THE PATIENT DID NOT HAVE AN MRI DURING THAT TIME, BUT HAD AN MRI LAST NIGHT. THE PATIENT TOLD THE REPORTER THAT HE DID NOT HEAR ANY ALARMS, BUT THE REPORTER HEARD THE ALARM WHILE ON THE PHONE WITH THE MANUFACTURER. IT WAS DISCUSSED UPDATING THE PUMP TO MIN RATE MODE TO PREVENT OVERDOSE IF THE PUMP RECOVERS. THE PUMP WAS USED TO DELIVER CLONIDINE AND MORPHINE ADDITIONAL INFORMATION LATER REPORTED THE CAUSE OF THE MOTOR STALL HAD NOT BEEN DETERMINED. THE DEVICE WAS SET TO MINIMUM RATE BY THE ICU RESIDENT AS THEY WERE MANAGING HIM ON OTHER IV MEDS, DEVICE STILL SHOWED MOTOR STALL WHEN REPROGRAMMED. ICU STAFF PLANNED TO STABILIZED THE PATIENT AND DISCHARGE HIM TO HIS MANAGING PHYSICIAN FOR FURTHER TREATMENT . ADDITIONAL INFORMATION LATER REPORTED THE MANAGING HCP REQUESTED TO HAVE THE PUMP TURNED OFF. ADDITIONAL INFORMATION LATER REPORTED THE PUMP WOULD BE REPLACED. ADDITIONAL INFORMATION LATER REPORTED THE PUMP WAS REPLACED (B)(6) 2013. THERE WAS NO INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17610 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization| R