BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED

    MDR report key: 5075058 · Received September 14, 2015

    Report

    Report Number
    6000030-2015-00123
    Event Type
    Death
    Date Received
    September 14, 2015
    Date of Event
    April 18, 1997
    Report Date
    September 1, 2015
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PREVIOUSLY REPORTED IN MFG. REPORT# 6000030199700170. THE HAS BEEN UPDATED AND ANY NEW INFORMATION WILL BE REPORTED UNDER THIS REPORT NUMBER. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8703, LOT# J92103106, PRODUCT TYPE: CATHETER. (B)(4). ANALYSIS OF THE PUMP, MODEL# 8615 , (B)(4), FOUND NO SIGNIFICANT ANOMALY. THE BATTERY DEPLETION WAS ASSUMED TO BE NORMAL. THE PUMP WAS RECEIVED INTO THE NEURO RPA LAB ON (B)(6) 2003 AND PLACED ON LEGAL HOLD. ON (B)(6) 2015, THE PUMP WAS RELEASED FROM LEGAL HOLD. THE PUMP WAS UNABLE TO INTERROGATED BECAUSE THE BATTERY WAS DEPLETED. NO FURTHER ANALYSIS CAN BE PERFORMED ON THIS PUMP.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING MORPHINE SULFATE ( 70.0MG/ML, 13.2MG/DAY) VIA AN IMPLANTABLE INFUSION PUMP [SUBSEQUENT PHONE CALL ON (B)(6) 1997 LISTED THE MORPHINE SULFATE CONCENTRATION AS 75.0MG/ML, DESPITE PUMP SESSION REPORT FROM THE REPORTED DATE OF DEATH LISTED THE CONCENTRATION AS 70.0MG/ML] THE INDICATIONS FOR USE INCLUDED NON-MALIGNANT PAIN. THE PATIENT EXPERIENCED INCREASED PAIN DESPITE INCREASED INFUSION RATES. THE PATIENT HAD BEEN CONCERNED OF THE PATENCY OF THE PUMP SYSTEM. THE DECISION WAS THEN MADE TO PERFORM A MYELOGRAM TO RULE OUT OBSTRUCTION OR KINKING OF THE CATHETER SYSTEM. A MYELOGRAM WAS PERFORMED ON (B)(6)1997 THROUGH THE PUMP UNDER FLUOROSCOPIC GUIDANCE. HOSPITAL RECORDS INDICATED ASPIRATION WAS PERFORMED (UNKNOWN HOW MUCH FLUID WAS ASPIRATED PRIOR TO CONTRAST INJECTION). THEN, CONTRAST DYE WAS INJECTED THROUGH THE SIDE PORT (CATHETER ACCESS PORT, CAP). THE CATHETER WAS VISUALIZED IN THE LOWER PORTION OF THE THORACIC SPINE. OBSTRUCTION OR LEAKAGE OF THE CATHETER SYSTEM WAS RULED OUT. THE PATIENT'S PUMP WAS THEN FLUSHED WITH A "0.3ML (21MG) BOLUS OF MEDICATION THROUGH THE PUMP TO CLEAR THE CATHETER SYSTEM." THE PATIENT TOLERATED THE PROCEDURE WELL AND WITHOUT APPARENT COMPLICATION. AFTER THE PROCEDURE, A SINGLE BOLUS DOSE OF 22.5MG WAS ADMINISTERED OVER 14 MINUTES AND 30 SECONDS (PER SESSION PRINT REPORT) TO "CLEAR THE PUMP." IT WAS UNCLEAR IF THE 0.3ML FLUSH AND THE PROGRAMMED BOLUS OF 22.5MG WERE REFERRING THE SAME ACTION TO CLEAR THE CATHETER. THE PATIENT WAS TAKEN HOME AND LIED DOWN FOR A NAP. AFTER SEVERAL HOURS, THE PATIENT'S HUSBAND COULD NOT WAKE HER AND AMBULANCE WAS CONTACTED. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AND WAS PRONOUNCED DEAD IN THE EMERGENCY ROOM (ER). AT THE TIME OF DEATH, THE PATIENT'S BLOOD MORPHINE LEVEL WAS 771.0 NANOGRAMS (NG)/M L (POTENTIALLY TOXIC LEVEL OF ANYTHING GREATER THAN 100NG/ML). THE MEDICAL EXAMINER RULE THE PATIENT DEATH AS MORPHINE OVERDOSE, DELIVERED THROUGH THE IMPLANTED PUMP. IT WAS THOUGHT A RELATIVELY LARGE AMOUNT OF MORPHINE SOLUTION WAS INJECTED THROUGH THE PUMP DURING THE COURSE OF THE MYELOGRAM AND/OR DURING THE SUBSEQUENT "FLUSHING" OF THE PUMP CATHETER. SINCE THE DEATH OCCURRED AS THE DIRECT RESULT OF MANIPULATION OF THE PUMP/TUBING WITH THE UNINTENTIONAL ADMINISTRATION OF AN EXCESSIVE DOSE OF MORPHINE, IT WAS IN THE OPINION OF THE MEDICAL EXAMINER THAT THE DEATH WAS ACCIDENTAL. THE MFG. REPORT# 6000030199700170, SUBMITTED ON (B)(6) 1997 REPORTED A CATHETER CONTRAST STUDY/MYELOGRAM WAS PERFORMED ON (B)(6) 1997 BECAUSE OF SOME CONCERN WITH THE PUMP, THE NATURE OF WHICH WAS UNKNOWN. THE HCP WAS UNABLE TO WITHDRAW THE MORPHINE SOLUTION FROM THE CATHETER BEFORE INJECTING THE DYE; THEREFORE, THE DRUG IN THE CATHETER BOLUSED WITH THE CONTRAST. IT WAS NOTED THAT THIS MEANT THE PATIENT MAY HAVE RECEIVED A 30 MG BOLUS OF MORPHINE. INTERVENTIONS INCLUDED MONITORING THE PATIENT FOR 30 MINUTES; THE PATIENT WAS DOING WELL AND WAS SENT HOME. LATER THAT DAY, THE PATIENT WAS UNABLE TO BE AROUSED. ON (B)(6) 1997, THE PUMP WAS REMOVED FROM THE PATIENT. THE PUMP WAS INTACT WITH AN ATTACHED CATHETER. THE PUMP WAS THEN HEARD TO EMIT AN AUDIBLE "BEEP." UPON INTERROGATION, A LOW BATTERY ALARM OCCURRED. IT WAS UNKNOWN WHEN THE ALARM FIRST BEGAN. PLEASE REFER TO THE PREVIOUSLY REPORTED TO THE PREVIOUSLY REPORTED MFG. REPORT# 6000030199700170 AND MFG. REPORT# 1832468-1997-0001. HISTORY: FINAL PATHOLOGIC DIAGNOSES INCLUDED: MORPHINE OVERDOSE, ACCIDENTAL; INTRATHECAL MORPHINE PUMP SYSTEM, FOR TREATMENT OF CHRONIC PAIN/BACK PAIN (INSTALLED 1992); MULTIPLE SEVERE INJURIES IN AUTOMOBILE ACCIDENT (1982), WITH SUBSEQUENT DEVELOPMENT OF CHRONIC BILATERAL LOWER EXTREMITY PAIN (MYOFASCIAL PAIN SYNDROME), BY HISTORY; POST TRAUMATIC GRAND MAL EPILEPSY (BY HISTORY); LAPAROTOMIES, REMOTE; FIBROUS INTRA-ABDOMINAL ADHESIONS; HYSTERECTOMY, REMOTE; APPENDECTOMY, REMOTE. CONCOMITANT DRUGS: TRAZODONE (50MG TAB, 1 OR 2 TAB TAKEN 2 HOURS BEFORE BED WITH TYLENOL PM; (B)(6) 1995), PRILOSEC (20MG, 1 TAB AT BREAKFAST; (B)(6) 1996), SALSALATE(750MG, 2TAB/DAY, BREAKFAST AND DINNER; (B)(6) 1669), CORGARD (40MG, 1TAB/DAY AT BED; 1993), PERMARIN (0.625 (UNITS NOT PROVIDED), 1 TAB/DAY AT BREAKFAST), MIACALCIN NASAL SPRAY (200 IU/DOSE, 1 DOSE AT BED; (B)(6) 1996), LORABID (200MG, 1 TAB 2 TIMES A DAY AS NEEDED), SUPER CALCIUM 1200 (600MG, 2TAB/DAY, BREAKFAST AND DINNER), TEGRETOL (100MG CHEWABLE TAB DOSING: (B)(6) 1995: CONCENTRATION 60MG/ML AT 10.0MG/DAY (B)(6) 1996: CONCENTRATION 70MG/ML AT 10.0MG/DAY (B)(6) 1996: CONCENTRATION 70MG/ML AT 12.0MG/DAY (B)(6)1997: CONCENTRATION 70MG/ML AT 12.0MG/DAY (B)(6) 1997: CONCENTRATION 70MG/ML AT 12.0MG/DAY; NEXT REFILL DUE (B)(6) 1997 : CONCENTRATION 70MG/ML AT 13.2MG/DAY; NEXT REFILL DUE (B)(6) 1997

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606449 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8615

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Death