SYNCHROMED II
Report
- Report Number
- 3004209178-2015-20368
- Event Type
- Death
- Date Received
- October 9, 2015
- Date of Event
- September 11, 2015
- Report Date
- September 11, 2015
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z-1570-2014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
ANALYSIS OF THE PUMP FOUND OVER-INFUSION WITH AN UNDETERMINED ROOT CAUSE. THE PREVIOUSLY REPORTED CONCLUSION CODES NO LONGER APPLY TO THE EVENT.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8590-1, LOT# N190037, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY. PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. (B)(4).
(B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: CATHETER. CONCLUSION REMOVED AS IT NO LONGER APPLIES TO THE EVENT AND REPLACED. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
ON 2015-09-11 INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA A DEVICE MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS RECEIVING SUFENTANIL 200MCG/ML AT A DOSE OF 42.02 MCG/DAY VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN AND POST LAMINECTOMY PAIN. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. ON 2015-09-16, INFORMATION WAS RECEIVED FROM A REP. A REFILL HAD OCCURRED, ON (B)(6) 2015 IN THE AFTERNOON, AND THE PATIENT'S MEDICATIONS WERE CHANGED. THEIR PUMP HAD BEEN DELIVERING SUFENTANIL AND BUPIVACAINE. AT THE REFILL, THE BUPIVACAINE WAS REMOVED BUT THE DAILY DOSE OF THE SUFENTANIL WASN'T CHANGED. THE REP HAD RECEIVED A PAGE ON (B)(6) 2015 REQUESTING ASSISTANCE WITH TURNING OFF THE PATIENT'S PUMP. THE HCP BELIEVED THE PATIENT WAS OVERDOSING "ON SOMETHING". THE PATIENT WAS INTUBATED AND NON-RESPONSIVE AT THE TIME OF THE INITIAL CALL. THE HCP ASKED THE REP HOW LONG IT WOULD TAKE THEM TO DRIVE TO THE HOSPITAL AND THE REP SAID IT WOULD TAKE 40 MINUTES. THE HCP THEN TOLD THE REP THE PATIENT WAS BEING TRANSFERRED TO ANOTHER HOSPITAL. AS A RESULT, THE REP CONTACTED 3 OTHER REPS IN THE AREA TO ASSIST AS IT WAS THEIR TERRITORY. EARLY THE NEXT MORNING, ON (B)(6) 2015, A REP RESPONDED AND PROGRAMMED THE PUMP TO MINIMUM RATE MODE DUE TO THE PATIENT BEING UNRESPONSIVE. THE LOGS WERE CHECKED AND NOTED TO BE NORMAL, THERE WERE NO EVENTS SEEN IN THE LOGS. THE RESERVOIR VOLUME WASN'T CHECKED TO THE REP'S KNOWLEDGE. FURTHER INFORMATION HAD ALSO BEEN RECEIVED FROM A REP, ON (B)(6) 2015. NO CAUSE HAD BEEN DETERMINED AND IT WAS NOTED THEY BELIEVED THE PATIENT'S SYMPTOMS WERE HEART RELATED PER THE PHYSICIAN AT THE HOSPITAL. THE PATIENT'S SYMPTOMS HADN'T BEEN RESOLVED AND THEY WERE STILL HOSPITALIZED. AS OF (B)(6) 2015, THE PATIENT WAS STILL IN THE HOSPITAL BUT THE REP WASN'T AWARE OF ANY ADDITIONAL INTERVENTIONS BEING PLANNED. ADDITIONAL INFORMATION WAS RECEIVED ON 2015-09-16 FROM ANOTHER REP WHO REPORTED THE PATIENT'S CURRENT STATUS WAS "BRAIN-DEAD" BUT THE PATIENT WAS STILL ON LIFE SUPPORT. THE REP HAD MET WITH THE HCP WHO REFILL THE PUMP AT THE MOST RECENT REFILL. THE PROGRAMMING WAS CORRECT. THE HCP DID ALL THEIR REFILLS UNDER ULTRASOUND AND THEY HAD REVIEWED THE VIDEO WHICH THEY HAD SAVED. THEY COULD SEE THE DRUG GO INTO THE RESERVOIR AS INTENDED. THE RESERVOIR VOLUMES AT REFILL WERE CORRECT, AS WELL. THE REP PLANNED TO CONTINUE TO MONITOR THE SITUATION AND WOULD REPORT BACK WITH ANY UPDATES. FURTHER INFORMATION WAS THEN RECEIVED FROM AN EVIDENCE COORDINATOR AT A CORONER'S OFFICE. THE PATIENT'S DEATH OF DEATH WAS NOTED AS (B)(6) 2015 AT 14:05 HOURS. IT WAS UNKNOWN IF THE DEATH WAS RELATED TO THE PATIENT'S DEVICE OR THERAPY. IN TERMS OF ALLEGATIONS AGAINST THE DEVICE, THE HCP BELIEVED THERE WAS A SUSPECTED OVERDOSE. THE CORONER'S OFFICE WAS SENDING THE PUMP BACK FOR ANALYSIS. THE CAUSE OF DEATH WAS PENDING; AN AUTOPSY WAS TO BE PERFORMED. THE REPORTER DIDN'T HAVE ACCESS TO THE PATIENT'S MEDICAL HISTORY. FURTHER INFORMATION WAS RECEIVED ON 2015-09-28 FROM THE HCP VIA A REP. THE HCP WAS ALARMED BY THE FOLLOW UP INFORMATION REQUESTED FROM THE DEVICE MANUFACTURER. THE HCP WAS REPORTEDLY STILL NOT CERTAIN OF THE CAUSE OF DEATH BUT HAD BEEN TOLD IT WAS "CARDIAC RELATED, SOME TYPE OF HEART IRREGULARITY". THE PATIENT HAD HEART ISSUES AND HAD RECENTLY BEEN DIAGNOSED WITH A CHIARI MALFORMATION. NO FURTHER INFORMATION WAS PROVIDED INCLUDING INFORMATION REGARDING THE SUSPECTED OVERDOSE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HEALTHCARE PROVIDER COULD NOT FIND THE VOLUME THAT WAS TAKEN OUT OF THE PUMP BUT SOME WAS TAKEN OUT AND SENT FOR TESTING. IT CAME BACK NORMAL OR AS EXPECTED AS THE DRUG IN THE PATIENT'S PUMP. THE TOXICOLOGY SCREEN SHOWED: BASIC VOLATILES (ETHANOL, METHANOL, ISOPROPANOL, ACETONE) NOT DETECTED. (B)(6) SCREEN: DRUGS OF ABUSE, (AMPHETAMINES, BENZODIAZEPINES, COCAINE, FENTANYL, OPIATES, OXYCODONE, TETRAHYDROCANNABINOL METABOLITE), NOT DETECTED. GC/MS BASIC DRUG SCREEN: BUPIVACAINE (MARCAINE), DIPHENHYDRAMINE, (BENADRYL) AND NORTRIPTYLINE (PAMELOR, METAB. OF AMITRIPTYLINE) PRESUMPTIVE I.D. AND CONFIRMATION AND QUANTITATION TESTS AND RESULTS: BUPIVICAINE (MARCAINE) NOT DETECTED AND SUFENTANIL (SUFENTA) NOT DETECTED.
INFORMATION WAS RECEIVED FROM THE OFFICE OF THE CORONER. IT WAS REPORTED THAT THE CAUSE OF DEATH OF THE PATIENT WAS ANOXIC ENCEPHALOPATHY DUE TO CARDIOPULMONARY ARREST OF UNDETERMINED ETIOLOGY. IT WAS THE CORONER'S OPINION THAT THE MANNER OF DEATH WAS UNDETERMINED. A HISTORY OF CARDIOPULMONARY ARREST AND RESUSCITATION WITH MARKED ENCEPHALOMALACIA WAS NOTED. THE TOXICOLOGY STUDIES FOR BUPIVACAINE AND SUFENTANIL WERE NEGATIVE. NO EVIDENCE OF SIGNIFICANT TRAUMA WAS IDENTIFIED. A POSTMORTEM EXAMINATION OF THE BODY OF THE PATIENT WAS PERFORMED ON (B)(6) 2015 AT 12:10 P.M. RIGOR MORTIS HAD DEVELOPED. LIVOR MORTIS WAS PURPLE, POSTERIOR, AND BLANCHES. THE BODY WAS COOL TO THE TOUCH IN THE PRESENCE OF REFRIGERATION. THE SCALP HAIR HAD GRAY-BROWN ROOTS AND WAS DYED RED. SCLERAE AND CONJUNCTIVAE WERE FREE OF PETECHIAE. IRIDES WERE BROWN AND THE ORAL CAVITY HAD NATURAL-APPEARING DENTITION. THE TRACHEA WAS MIDLINE. THE CHEST HAD A NORMAL ANTERIOR-POSTERIOR DIAMETER AND THE ABDOMEN WAS FLAT. THE EXTREMITIES WERE EQUAL AND SYMMETRICALLY DEVELOPED. THE BACK, BUTTOCKS, AND ANUS WERE NORMALLY FORMED. THE EXTERNAL GENITALIA WERE THOSE OF AN ADULT FEMALE. THE PATIENT HAD A 6 INCH SCAR ON THE ANTERIOR SURFACE OF THE RIGHT KNEE. EVIDENCE OF MEDICAL INTERVENTION INCLUDED A PRESSURE CUFF ON THE PATIENT'S LEFT ARM; AN ENDOTRACHEAL TUBE THAT PROTRUDED FROM THE MOUTH; A NASOGASTRIC TUBE THAT WAS IN PLACE; AND AN INDWELLING INTRAVASCULAR CATHETER THAT PROTRUDED FROM THE RIGHT ANTECUBITAL FOSSA, THE LEFT ARM AND THE BACK OF THE LEFT HAND. AN IMPLANTED MEDICATION DELIVERY DEVICE WAS IN THE REGION OF THE RIGHT HIP. THE BODY HAD UNDERGONE POSTMORTEM ORGAN DONATION AS THE HEART AND LIVER WERE UNAVAILABLE FOR EXAMINATION. A 24 INCH POSTMORTEM SURGICAL INCISION EXTENDED FROM THE SUPRASTERNAL NOTCH TO THE XIPHOID PROCESS. INTERNAL EXAMINATION CONSISTED OF THE PANNICULUS ADIPOSUS OF THE ANTERIOR ABDOMINAL WALL WAS APPROXIMATELY 1/2 INCH IN THICKNESS. THE SEROSAL SURFACES WERE WET, SMOOTH AND GLISTENING. THE OMENTUM AND MESENTERY WERE NORMAL IN CONFIGURATION AND FREE OF ABNORMAL MARKINGS. THE THORACIC AND ABDOMINAL ORGANS HAD THEIR USUAL ANATOMIC RELATIONSHIPS. THE TRACHEOBRONCHIAL TREE WAS PATENT AND THE MUCOSAL SURFACE WAS INTACT. THE 450 GRAM RIGHT LUNG AND 375 GRAM LEFT LUNG WERE OF NORMAL LOBATION. PLEURAL SURFACES WERE SMOOTH AND GLISTENING. THE CUT SURFACES WERE FREE OF PALPABLE INDURATION AND CONSOLIDATION. HILAR LYMPH NODES WERE NO ENLARGED AND WERE NOT SOFT. PULMONARY ARTERIES WERE FREE OF THROMBOEMBOLI AND PATENT. THIRTY GRAMS OF THE SPLEEN REMAINED AFTER THE DONATION PROCESS. THE CUT SURFACE AWAY FROM AREAS OF ALTERATION WAS FREE OF ABNORMAL MARKINGS. NO ENLARGED OR OTHERWISE ABNORMAL LYMPH NODES WERE ENCOUNTERED DURING THE COURSE OF THE AUTOPSY. THE BONE MARROW, WHERE SEE, HAD AN UNREMARKABLE CUT SURFACE. THE THYMUS WAS APPROPRIATE IN SIZE AND CONFIGURATION FOR THE AGE OF THE DECEDENT. ADRENAL GLANDS WERE NORMAL IN SIZE AND CONFIGURATION. THE YELLOW AND BROWN CORTICAL AND THIN, GRAY MEDULLARY ZONES WERE FREE OF HEMORRHAGIC AND OTHER ABNORMAL MARKINGS. THE THYROID GLAND WAS NORMAL IN SIZE AND CONFIGURATION AND HAD AN UNREMARKABLE CUT SURFACE. THE PITUITARY GLAND WAS GROSSLY NORMAL. THE PANCREAS WAS NORMAL IN SIZE AND CONFIGURATION. THE LOBULATED YELLOW-BROWN CUT SURFACE IS FREE OF FOCAL ABNORMAL MARKINGS. THE 370 GRAM IN AGGREGATE KIDNEYS WERE ROUGHLY EQUAL IN SIZE. THE CAPSULES WERE THIN AND EASILY STRIPPED FROM SMOOTH CORTICAL SURFACES. THE CORTICAL ZONES WERE OF AVERAGE WIDTH AND WELL-DEMARCATED FROM MEDULLARY ZONES. CALYCES, PELVES AND URETERS WERE NORMAL IN CONFIGURATION. THE URINARY BLADDER CONTAINED A FOLEY CATHETER. THE BLADDER MUCOSA WAS INTACT. THE VAGINA HAD A RUGATED GRAY MUCOSAL LINING FREE OF TRAUMA. THE UTERUS, TUBES, AND OVARIES WERE REMOTELY ABSENT. THE ESOPHAGEAL MUCOSA WAS INTACT. OTHER THAN ALTERATIONS FROM POSTMORTEM ORGAN HARVESTING, NO ADDITIONAL ABNORMALITIES WERE NOTED OF THE LARGE OR SMALL INTESTINE. THE ANTERIOR STRAP MUSCLES OF THE NECK AND SOFT TISSUE OVERLYING THE UNFRACTURED CERVICAL SPINE WERE FREE OF HEMORRHAGIC AND OTHER ABNORMAL MARKINGS. THE HYOID BONE AND CARTILAGINOUS STRUCTURES OF THE LARYNX WERE INTACT. THE LARYNGEAL MUCOSA WAS FREE OF ABNORMAL MARKINGS. THE UNDERSURFACE OF THE SCALP WAS FREE OF HEMORRHAGIC AND OTHER ABNORMAL MARKINGS AND THE CALVARIUM AND DURA WERE INTACT. THE 1440 GRAM BRAIN WAS COVERED BY SMOOTH, GLISTENING, TRANSPARENT LEPTOMENINGES. LARGE ARTERIES OVER THE BASE OF THE BRAIN WERE NORMALLY DISTRIBUTED, THIN-WALLED, AND PATENT. SECTIONS OF THE HEMISPHERES HAD A NORMAL ARCHITECTURE OF THE CORTICAL AND GANGLIONIC GRAY MATTER AND CENTRAL WHITE MATTER. VENTRICLES WERE NORMAL IN SIZE AND CONFIGURATION AND HAD SMOOTH, GLISTENING EPENDY MAL LININGS AND WATERY CONTENTS. SECTIONS OF THE CEREBELLUM, PONS, AND MEDULLA HAD A NORMAL ARCHITECTURE OF THESE STRUCTURES. NO ABNORMALITIES WERE NOTED OF THE AXIAL OR APPENDICULAR SKELETON. THE MUSCULATURE WAS NORMALLY DEVELOPED. THE DIAPHRAGM WAS SMOOTH, GLISTENING AND FREE OF ABNORMAL MARKINGS. MICROSCOPIC EXAMINATION TOOK PLACE OF THE LUNGS, ATELECTASIS, KIDNEY, SPLEEN, BRAIN, ADRENAL GLAND, AND THYROID GLAND; NO SIGNIFICANT HISTOPATHOLOGIC ABNORMALITY IN SECTIONS EXAMINED.
ADDITIONAL INFORMATION WAS REPORTED BY THE HEALTHCARE PROVIDER (HCP) NOTED THAT THE DECEDENT HAD A REFILL OF THE PUMP ON (B)(6) 2015 HOURS BEFORE BEING FOUND UNRESPONSIVE AT HOME. THE DEVICE WAS EXPLANTED ON (B)(6) 2015 AND A SMALL AMOUNT OF MEDICATION WAS REMOVED FROM THE PUMP FOR DRUG ANALYSIS. THE REMAINING AMOUNT OF MEDICATION IN THE PUMP WAS TO BE MEASURED DURING ANALYSIS OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 671850 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00044 YR | Death| H| L| R |