BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3123986 · Received May 22, 2013

    Report

    Report Number
    3004209178-2013-08027
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 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
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), EXPLANTED (B)(6) 2013, PRODUCT TYPE - CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: CATHETER: PRODUCT ID 8835, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS STILL NO KNOWN CAUSE TO THE PATIENT OVERDOSE. THE PATIENT HAD BEEN HISTORICALLY DIFFICULT TO FILL, BUT THERE WERE NO FURTHER DOCUMENTED ISSUES. THE PATIENT VOLUME WAS CHECKED ¿AT TIME OF CHANGE OUT¿, BUT SPECIFIC VOLUMES OR FURTHER INFORMATION WAS NOT PROVIDED. IT WAS LATER REPORTED THAT THE CAUSE OF THE OVERDOSE EVENT WAS ¿DIFFICULT PUMP POSITIONING-PUMP REFILL DONE UNDER FLUOROSCOPY¿. THE PUMP CONTENTS WERE NOT ASPIRATED FOR VERIFICATION FOLLOWING RESOLUTION OF THE OVERDOSE, PER THE HEALTHCARE PROVIDER (HCP). THE HCP FURTHER OFFERED REGARDING THE OVERDOSE ¿PUMP REFILL-MEDICATION LEAKED INTO POCKET OF ABDOMEN¿. AN ULTRASOUND OF THE PATIENT¿S ABDOMEN WAS DONE IN THE HOSPITAL ON (B)(6) 2013, ALTHOUGH RESULTS WERE NO REPORTED. THE PATIENT WAS HOSPITALIZED AS A RESULT OF THE EVENT, FOR MONITORING. THE PATIENT SUBSEQUENTLY UNDERWENT A SCHEDULED PUMP REPLACEMENT ON (B)(6) 2013, AT WHICH TIME THE CATHETER WAS FOUND TO BE DISLODGED. THE PATIENT OUTCOME WAS REPORTED AS RECOVERED WITHOUT SEQUELAE AS OF (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS REFILL DIFFICULTY THE WEEK PRIOR TO THE DATE OF THIS REPORT AND THE PATIENT EXPERIENCED OVERDOSE SYMPTOMS. THE PUMP WAS IN SLANTED POSITION. THE PUMP WAS ACCESSED UNDER THE FLUOROSCOPY. THE EXPECTED VOLUME WAS 10 ML AND THE ACTUAL VOLUME WAS 3.5 ML. IT WAS NOTED THAT A REFILL KIT WAS USED AND VACUUM CREATED. SMALL AMOUNT OF DRUG WAS INFUSED AND EXTRACTED DURING THE FILLING PROCESS. WHEN 40 ML OF DRUG WAS INFUSED IN THE PUMP, LATERAL VIEW WAS CHECKED TO VERIFY EXPANSION OF BELLOWS. IT WAS NOTED THAT WHEN THE PATIENT WALKED BACK TO THE CLINIC, THE PATIENT¿S MOUTH FELT ¿REALLY DRY¿ AND SHE ¿DID NOT FEEL NORMAL.¿ THE PATIENT WAS TAKEN BACK TO AMBULATORY SURGERY CENTER FOR HEMODYNAMIC MONITORING. THE PATIENT REMAINED HEMODYNAMICALLY STABLE BUT CONTINUED TO COMPLAIN OF DRY MOUTH AND NUMB LIPS. ABOUT 30 MINUTES POST REFILL, THE PATIENT SUDDENLY TURNED BLUE AND BECAME NON-RESPONSIVE. LOSS OF CONSCIOUSNESS WAS ALSO REPORTED. CARDIOPULMONARY RESUSCITATION WAS INITIATED. NARCAN WAS GIVEN WHICH THE PATIENT RESPONDED. THE PATIENT WAS TRANSFERRED VIA AMBULANCE TO THE HOSPITAL. THE PATIENT WAS IN INTENSIVE CARE UNIT BEING MONITORED BUT HAD BEEN STABLE SINCE TRANSFER. THE PATIENT OUTCOME WAS NOTED AS NO INJURY. THE PUMP WAS BEING USED TO DELIVER MORPHINE, BACLOFEN AND BUPIVACAINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER RECEIVED REPORTED THAT THE HCP'S OFFICE 'POCKET FILLED' THE PATIENT AND CAUSED THE PATIENT TO 'DIE' TWICE IN ONE DAY. THE PATIENT HAD A FULL CARDIAC ARREST, UNRESPONSIVE FOR 4 MINUTES .AS SOON AS THE PATIENT GOT TO HOSPITAL 'DIED AGAIN' AND WENT INTO FULL RESPIRATORY ARREST. THE PATIENT WAS IN ICU (INTENSIVE CARE UNIT) FOR 5 DAYS. PER THE PATIENT THEY GAVE HER 800 TIMES THE LEGAL DOSE OF MORPHINE AND THAT'S WHAT KILLER HER. THE PATIENT HAD TO HAVE PUMP REPLACED. THE PATIENT STATED IT HELPS THE PATIENT. THE DOCTOR'S OFFICE CLAIMED IT WAS IN A BAD PLACEMENT AND THAT WAS THE POCKET FILL ISSUE. THE PATIENT STATED THEY WERE SCARED TO DEATH OF THE PATIENT. THE PATIENT'S REFILL DATE WAS (B)(6). THE PATIENT WAS SEEKING A NEW HCP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED THAT PER THE PATIENT THEIR LAST PUMP WAS "PUT IN WRONG" AND THE PATIENT HAD A POCKET FILL. THIS OCCURRED (B)(6) OF LAST YEAR. THE POCKET FILL RESULTED IN CARDIAC ARREST AND RESPIRATORY FAILURE THE SAME DAY. PER THE PATIENT AT THE TIME SHE WAS "SET AT 13" WITH 4 BOLUSES A DAY AND "NOW I'M AT .0000256". THE POCKET FILL LED TO PUMP REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225886 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Hospitalization| L| R