SYNCHROMED II
Report
- Report Number
- 3004209178-2013-11044
- Event Type
- Injury
- Date Received
- June 28, 2013
- Report Date
- June 5, 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
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
PRODUCT ID: 8703W LOT# L34928, IMPLANTED: 1995 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: 8840 LOT# SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN PRODUCT ID: 8840 LOT# SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4) .
(B)(4).
(B)(4).
(B)(4).
IT WAS LATER REPORTED THE PUMP EMPTY RESERVOIR ALARM WAS (B)(6) 2013. THE PUMP WAS EMPTY (APPROPRIATE) AND FILLED WITH PRESERVATIVE FREE NORMAL SALINE ON (B)(6) 2013. THE PUMP WAS DRY FOR SIX WEEKS. A BRIDGE BOLUS WAS DONE. THE BOLUS WAS ATTEMPTED TO SEE IF THE PUMP WAS STILL FUNCTIONING AS IT WAS DRY FOR SIX WEEKS. AFTER FURTHER CONSIDERATION HCP WENT TO THE PATIENT¿S HOME AND PUT THE PUMP BACK TO MINIMAL RATE. AT THE TIME THE PUMP HAD DELIVERED 0.6 ML PER INTERROGATION. THE PATIENT WAS ALERT, ACTIVE AND ORIENTED TIMES FOUR. THIS WAS ABOUT THREE HOURS AFTER THE BOLUS. THE NEXT MORNING HE WAS FOUND WITH MENTAL STATUS CHANGES AND RESPIRATORY DEPRESSION. THE PATIENT OUTCOME WAS SERIOUS INJURY/ILLNESS-ONGOING. THE PUMP WAS DELIVERING PRESERVATIVE FREE NORMAL SALINE.
IT WAS REPORTED THAT THE PATIENT¿S PUMP HAD BEEN DRY SINCE THE (B)(6) 2013. THE PATIENT¿S HEALTHCARE PROVIDER (HCP) ASKED IF THE PUMP NEEDED TO BE REPLACED. THE CALLER DISCUSSED WITH THE HCP TO FILL THE PUMP WITH SALINE AND RUN THE PUMP AT A HIGH RATE AND THEN TO ASSESS THE PUMP FOR VOLUME DISCREPANCY. THE CALLER ALSO DISCUSSED THE POTENTIAL THAT THE ROTOR MAY HAVE BEEN ¿PINCHED¿ AND FILLING WITH SALINE WAS A WAY TO TEST IF THERE WAS ANY DAMAGE. THE HCP RESPONDED ¿HMM THAT¿S INTERESTING¿ AND REPORTED HE NEEDED TO RETURN TO THE CLINIC. THE REPORTED CALLED THE HCP BACK AT 1:59 THE SAME DAY, 2013 (B)(6), AND EXPLAINED TO THE HCP THAT DRUG WAS STILL IN THE PUMP TUBING. THE HCP HAD ALREADY FILLED THE PUMP WITH SALINE AND PROGRAMMED A BRIDGE BOLUS. THE HCP DID NOT CONSIDER THE DRUG IN THE PATH. IT WAS DISCUSSED THAT THE PUMP TUBING VOLUME WAS 0.3ML; HOWEVER, THE HCP WAS UNSURE OF THE CATHETER VOLUME. THE HCP WAS NOT WORRIED ABOUT THE DRUG IN THE CATHETER BECAUSE, HE FIGURED IN ¿DIFFUSION¿. THE CALLER STATED THAT THE PATIENT HAD A HIGH CONCENTRATION OF DRUG AND DISCUSSED STOPPING THE BOLUS WITH THE HCP BUT THE PATIENT HAD ALREADY LEFT TO GO HOME. THE CALLER WENT TO THE CLINIC AND DROVE THE HCP TO THE PATIENT¿S HOME. THE HCP WAS THEN ABLE TO STOP THE BOLUS AND PROGRAM THE PUMP TO MINIMUM RATE. AT THIS TIME, THE PATIENT WAS ¿COHERENT AND SEEMED FINE¿. THE PATIENT WAS SWEATY BUT HAD BEEN SITTING IN A CAR IN 90 DEGREE HEAT. THE REPORTER CALLED THE PATIENT ON THE DAY OF THE REPORT AND FOUND OUT THAT THE PATIENT WAS CURRENTLY IN THE INTENSIVE CARE UNIT (ICU). THE CALLER STATED THAT THE PUMP LOGS SHOWED THE ALARM DATE WAS 2013 (B)(6) AND THE RESERVOIR VOLUME WAS 0ML. THE ALARM DATE WAS ¿EARLY TO (B)(6)¿ AND THE PATIENT HAD STATED THAT THE REFILL DATE WAS ¿(B)(6)¿. THE CALLER STATED THAT THE PATIENT HAD REPORTED WITHDRAWAL AFTER THE MISSED REFILL IN (B)(6) AND AN HCP WAS NOT FOUND TO MANAGE THE PATIENT¿S PUMP. IT WAS NOTED THAT THE EMPTY RESERVOIR ALARM HAD SOUNDED. THE DEVICE SYSTEM DELIVERED DILAUDID, CLONIDINE AND MARCAINE. IT WAS LATER REPORTED THAT THE PATIENT STARTED FEELING ¿POOR¿ ABOUT 9PM THE NIGHT PRIOR TO THE REPORT AND APPROXIMATELY 5 HOURS AFTER THE PUMP WAS PROGRAMMED TO MINIMUM RATE. THE PATIENT¿S WIFE CONFIRMED THAT THE PATIENT HAD TAKEN ABOUT 5 VALIUM. THE PATIENT WAS THEN SENT TO THE ICU. THE PATIENT WAS TREATED WITH NARCAN IN THE ICU WHICH HE DID NOT RESPOND TO. THE PATIENT WAS THEN TREATED WITH THE REVERSAL AGENT FOR BENZODIAZEPINES AND HE RESPONDED WHICH LED THEM TO BELIEVE THE EVENT WAS FROM THE VALIUM OPPOSED TO OPIATE. THE CALLER WAS UNSURE IF THE PATIENT HAD TAKEN THE VALIUM DUE TO THE EFFECTS OF THE CLONIDINE IN THE PUMP WHICH ¿COULD HAVE BEEN A SYNERGISTIC EFFECT¿. THE CALLER STATED THAT THE PATIENT WAS NOT OPIOID NAÏVE AS HE HAD A DURAGESIC PATCH ON AND HAD BEEN RECEIVING ABOUT 7.5MG INTRATHECAL DILAUDID PRIOR TO THE PUMP RUNNING DRY. THE CALLER DISCUSSED WITH THE HCP ABOUT THE CATHETER VOLUME AND THAT IT WAS ¿PRETTY MUCH IMPOSSIBLE¿ TO DO AN EFFECTIVE BRIDGE BOLUS AND THE HCP AGREED. THE PATIENT WAS CURRENTLY RESPONDING TO THE TREATMENT BUT ¿HAD A ROUGH NIGHT¿. THE CALLER STATED THAT THE HCP HAD BEEN USING ¿RIDICULOUS CONCENTRATIONS OF DRUGS¿ INCLUDING DILAUDID 50MG/ML AND STATED ¿IT¿S NOT GOOD¿. PER THE PUMP LOGS, THE CONCENTRATION AND DOSE OF THE MEDICATIONS WERE DILAUDID 50MG/ML AT 7.761MG/DAY, CLONIDINE 250MCG/ML AT 38.80MCG/DAY, AND MARCAINE 0.9MG/ML AT 0.13970MG/DAY. THE PLAN WAS TO REFILL THE PUMP WITH SALINE AND CHECK THE RESERVOIR IN 1 WEEK. IT WAS LATER REPORTED THAT THE PATIENT REMAINED IN CRITICAL CONDITION AND HE WAS HEAVILY SEDATED AND INTUBATED. THE PATIENT¿S DIAGNOSIS WAS OVERDOSE AND ASPIRATION PNEUMONIA AS WELL AS A SPINAL CORD INJURY PATIENT FROM A PAST SURGERY TO REMOVE A TUMOR. THE PATIENT WAS ALSO HAVING ¿RENAL ISSUES¿. THE PATIENT¿S DAUGHTER, WHO WAS ALSO A PHYSICIAN, BELIEVED THE DEVICE DELIVERED MORPHINE, CLONIDINE AND DILAUDID AND THE REPORTER STATED THAT THE DEVICE DID NOT DELIVER DILAUDID, BUT MORPHINE, CLONIDINE AND BUPIVACAINE. THE DAUGHTER STATED THAT THE PATIENT WAS A SEVERE CHRONIC PAIN PATIENT AND HAD BEEN IN PAIN FOR A LONG TIME. THE DAUGHTER HAD BROUGHT THE PATIENT TO LIVE WITH HER IN (B)(6) 2013. THE TUESDAY FOLLOWING THE MISSED REFILL IN (B)(6) THE PATIENT SAW A PAIN SPECIALIST WHO RECOMMENDED FLUSHING THE PUMP WITH SALINE; HOWEVER, THE PATIENT¿S DOCTOR WANTED TO CHECK FOR VOLUME DISCREPANCY. THE PATIENT WAS SENT HOME AND DURING THAT TIME THE DAUGHTER BELIEVED THE PATIENT RECEIVED THE PUMP MEDICATION AS WELL AS HAD BEEN PRESCRIBED DURAGESIC AND INTERIM BETWEEN THE PUMP RUNNING DRY AS WELL AS OTHER MEDICATION. THE CALLER ALSO BELIEVED THE PATIENT HAD BREAKTHROUGH MORPHINE. TUESDAY NIGHT THE PATIENT ¿WENT DOWNHILL¿ AND AT SOME POINT ASPIRATED AND WAS TAKEN TO THE HOSPITAL BY HIS WIFE, EITHER BY AMBULANCE OR DRIVEN, ON 2013 (B)(6). IT WAS LATER REPORTED VIA A HCP THAT ON 2013 (B)(6) THEY WERE TRYING TO FILL THE PATIENT¿S PUMP AND THE PATIENT ¿SOMEHOW AT LEAST BY INTERROGATION¿ GOT A HIGHER DOSE THAN PLANNED; THE PATIENT WAS OVERDOSED. THE PATIENT ENDED UP HAVING A ¿RESPIRATORY EVENT¿ AND RE TURNING TO THE HOSPITAL. THE PATIENT WAS STILL IN THE HOSPITAL; HOWEVER, THE HCP WAS IN SEARCH FOR A SPECIALIST TO TAKE OVER THE PUMP SO THAT HE COULD DISCHARGE THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS FURTHER REPORTED THAT 12 HOURS AFTER THE PUMP WAS FILLED WITH SALINE AND PROGRAMMED TO MINIMUM RATE, THE PATIENT EXPERIENCED OVERDOSE AND WAS FOUND UNRESPONSIVE. THE PATIENT RECOVERED AND HAD THE PUMP REPLACED IN 2014.
IT WAS FURTHER REPORTED THAT AFTER THE PUMP RAN OUT OF MEDICATION AS PREVIOUSLY REPORTED, THE PATIENT WAS REFERRED A PAIN CLINIC WHERE THEY "ADJUSTED THE PUMP AND FLUSHED WITH SALINE". THE PUMP WAS FILLED WITH SALINE. REPORTEDLY, THE PATIENT MAY HAVE RECEIVED THE EQUIVALENT OF 30 MG OF DILAUDID BECAUSE OF THE FLUSH. PATIENT BECAME OBTUNDED WITHIN A DAY OR SO FROM "FLUSH." PATIENT WAS NOW BEING MANAGED ANOTHER PHYSICIAN AS AN OUTPATIENT. THE PATIENT WAS NOW AFRAID TO TRUST HIS PUMP BECAUSE OF PREVIOUS EXPERIENCE AND WAS INSISTENT HIS PUMP WOULD "RUN OUT" IN FIVE YEARS. IT WAS UNCLEAR AS TO WHAT MEDICATION THIS DEVICE SYSTEM WAS NOW DELIVERING. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 297181 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00057 YR | Hospitalization| L| O| R |