BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3191491 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10944
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 1, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8703W, LOT# L78428, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: CATHETER. PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: NEU_UNKNOWN_CATH, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. PRODUCT ID: 8840 LOT# SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER PHYSICIAN. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING A ROUTINE PUMP REPLACEMENT ON (B)(6) 2013, THE PUMP WAS REPROGRAMMED ON (B)(6) 2013 PTM WAS PROGRAMMED; SUBSEQUENTLY ON (B)(6) 2013, @ 0021, THE LOW RESERVOIR ALARM OCCURRED DESPITE THE RESERVOIR VOLUME BEING > THEN THE 2ML LOW ALARM VOLUME. THE PATIENT WAS BROUGHT TO CLINIC AND THE ALARM SILENCED ON (B)(6) 2013, BUT THE LOW ALARM RESERVOIR ALARM WAS STILL OCCURRING AS OF THE DATE OF REPORT. THE HCP WAS PLANNING TO FILL THE PUMP WITH 20ML OF DRUG WHICH WOULD SILENCE THE LOW ALARM. THE PUMP STATUS POST UPDATE RESERVOIR VOLUME 20ML, LOW RESERVOIR ALARM 4ML, WAS NO ACTIVE ALARMS PRESENT. THERE WERE NO PATIENT SYMPTOMS OR THERAPY PROBLEMS. THE PUMP WAS USED TO DELIVER CLONIDINE, BUPIVACAINE AND HYDROMORPHONE. THE HCP REPORTED LATER THAT DAY THAT THERE WAS NO CHANGE TO THE RESERVOIR VOLUME DURING PROGRAMMING OF PTM SETTINGS ON (B)(6) 2013. THE HCP CONFIRMED THE PATIENT WAS IN THE CLINIC AGAIN ON THE DAY OF REPORT TO HAVE THE REMAINING 20ML OF THE TOTAL 40ML OF DRUG FILLED INTO THE PUMP. THERE WERE NO AUDIBLE ALARMS REPORTED, AND NO PATIENT ISSUES. IT WAS LATER REPORTED THAT THE LOW RESERVOIR ALARM MAY HAVE BEEN TRIGGERED BY MAKING SWITCHES TO THE RESERVOIR ALARM VOLUME. THE REPORTER INDICATED THAT THE PUMP WAS ALARMING PRIOR TO HER FILLING AND UPDATING THE PUMP ON SATURDAY (B)(6) 2013. THE PUMP WAS NO LONGER ALARMING SINCE SHE TURNED OFF THE PTM. THE HCP REFILLED THE PUMP ON (B)(6) 2013, WITH AN ADDITIONAL 20ML, AND THINKS THERE WAS A CORRELATION WITH THE PTM AND THE ALARM. THE PUMP WAS ALARMING LOW RESERVOIR WITH THE ALARM SET AT 2ML, BUT THE PUMP CONTAINED 4ML. IT WAS REITERATED THAT AFTER THE HCP UPDATED THE PUMP ON (B)(6) 2013, THE PUMP STARTED ALARMING LOW RESERVOIR ON (B)(6) 2013. ALTHOUGH THERE WAS NO KNOWN CORRELATION BETWEEN THE ALARM AND THE PTM, THE HCP WAS HESITANT TO TURN THE PTM BACK ON. IT WAS LATER REPORTED THAT THE LATENT ALARM WAS CAUSED BY THE PROGRAMMING THAT OCCURRED ON (B)(6) 2013. THE LATENT ALARM WOULD HAVE B EEN TRIGGERED BY PROGRAMMING AND UPDATES DONE WITH THE RESERVOIR VOLUME, AND REVERTING THE INITIAL CHANGE, ON (B)(6) 2013. IT WAS DETERMINED THAT THE ALARM ABSOLUTELY WOULD NOT BE CAUSED BY ANY PTM PROGRAMMING OR ISSUE. THE REPORTER CONFIRMED THE ALARM HAS CLEARED AND NO FURTHER ALARMS WERE NOTED. IT WAS LATER REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN TO THE HCP, ALTHOUGH COUPLING WITH THE PTM WAS STILL SUSPECTED BY THE HCP. THE PATIENT¿S PUMP ALARM WAS SILENCED AND THE PUMP WAS REFILLED ON (B)(6) 2013, AND THE OUTCOME WAS REPORTED AS RESOLVED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291312 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR