BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3127783 · Received May 23, 2013

    Report

    Report Number
    3004209178-2013-08123
    Event Type
    Injury
    Date Received
    May 23, 2013
    Report Date
    April 25, 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
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8590-1, LOT# N150385, IMPLANTED: (B)(6) 2008, PRODUCT TYPE ACCESSORY; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER; PRODUCT ID 8832, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS STATED THAT AS REPORTED PREVIOUSLY PATIENT HAD BEEN ADMITTED TO THE HOSPITAL BUT THEY WERE UNABLE TO DETERMINE IF HER SYMPTOMS OF NAUSEA/VOMITING, DEHYDRATION AND INCREASED PAIN WERE RELATED TO POSSIBLE WITHDRAWAL OR IF FROM IT WAS FROM CANCER PROGRESSION. THEY FOUND THAT PATIENT HAD METASTATIC CANCER / DISEASE PROGRESSION. THERE WAS NO INTERVENTION AND NO PATIENT INJURY WAS STATED. ON (B)(6) 2013 THEY HAD RECHECKED THE VOLUME IN THE PUMP AND THE ACTUAL WAS 17ML AND THE EXPECTED WAS 18ML. PER REPORTER IT WAS UNKNOWN BUT PATIENT MAY HAVE BEEN HOSPITALIZED DUE TO CANCER PROGRESSION.

    Description of Event or Problem · 1

    VOLUME DISCREPANCIES WERE REPORTED. IT WAS STATED THAT PATIENT HAD BEEN VERY STABLE IN TERMS OF HER PUMP DOSE. SHE WAS ST 1.6 MILLIGRAMS OF HYDROMORPHONE AND BUPIVACAINE A DAY FOR LIKE FOUR OR FIVE YEARS AT THIS POINT. SHE GETS HER REFILLS IN ABOUT EVERY 120 DAYS. VOLUME DISCREPANCIES WERE NOTED BY THE HEALTHCARE PROVIDER (HCP) SINCE (B)(6) 2012. IN (B)(6), THEY EXPECTED 9.7 AND ASPIRATED 6. IN (B)(6), THE EXPECTED WAS 10.7 AND THEY GOT 8.6; IN DECEMBER, THEY EXPECTED 9.9 AND PULLED OUT 7. AS OF THE DATE OF THIS REPORT THEY¿D EXPECTED 9.7 AND BARELY PULLED OUT 1. THEY WERE ABLE TO REFILL THE PUMP COMPLETELY. IT WAS ADDED PATIENT WAS A CANCER PATIENT, LUNG CANCER, HAD A RECURRENCE "MORE CANCER NOW IN HER CHEST, METASTASIS TO THE BRAIN", ¿GOT MORE METS IN HER¿. PATIENT HAD RADIATION TREATMENT LAST WEEK, HAD BECOME VERY DEHYDRATED; ¿A LOT OF STUFF WAS GOING ON WITH HER RIGHT NOW SINCE THE PAST FEW MONTHS¿. PATIENT WAS IN THE HOSPITAL AND WAS GETTING PUMP REFILLED ON THE MORNING OF THE DATE OF THIS REPORT. PER REPORTER THEY COULD NOT DISCERN THROUGH EVERYTHING THAT¿S GOING ON THAT SHE¿S HAD ANY SYMPTOMS OF BEING OVERDOSED OR HAD BEEN AFFECTED BY THE VOLUME DISCREPANCIES; ¿BUT, OBVIOUSLY SHE WAS GETTING MORE THAN WHAT THEY WERE PROGRAMMING HER¿. HER PUMP ERI (ELECTIVE REPLACEMENT INDICATOR) SHOWED 22 MONTHS AND HCP WAS WONDERING OF MAYBE THE NEED OF A NEW PUMP. HOWEVER WITH ¿EVERYTHING GOING ON WITH HER AND THIS EXACERBATION, AND SHE¿S MISERABLE ALREADY RIGHT NOW, THEY WERE NOT COMFORTABLE TRYING TO MANAGE POTENTIAL WITHDRAWAL, WANT HER TO HAVE ANY MORE PAIN¿. ¿THEY DON¿T KNOW WHAT HER PROGNOSIS WAS AT THIS POINT IN TIME EITHER, SO EVEN ANOTHER SURGERY WAS NOT GOOD¿. SINCE PATIENT WAS IS THE HOSPITAL THEY WERE HOPING TO HAVE HER FOR ANOTHER COUPLE DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230418 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization