ALARIS SYSTEM
Report
- Report Number
- 2016493-2021-69755
- Event Type
- Death
- Date Received
- November 9, 2021
- Date of Event
- October 30, 2018
- Report Date
- November 25, 2021
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810015
- PMA / PMN Number
- K133532
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. THE ACTUAL DATE OF DEATH IS UNKNOWN. THE EVENT LOGS HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER. NO DEVICES RECEIVED, LOG REVIEW ONLY.
IT WAS DETERMINED THROUGH INVESTIGATION OF THE PCU DEVICE LOGS THAT THE INITIALLY REPORTED SUSPECT DEVICE WITH SERIAL NUMBER# (B)(4) IS A CONCOMITANT AND THIS FILE HAS CAPTURED THE CORRECT SUSPECT DEVICE WITH SERIAL NUMBER# (B)(4) AS PER INVESTIGATION REPORT.
IT WAS REPORTED THAT AN IMMUNOCOMPROMISED PATIENT WITH MENTAL STATUS CHANGES AND SUSPECTED MENINGITIS WAS BEING SEDATED WITH PROPOFOL THROUGH INFUSION PUMP (100ML BOTTLE, CONCENTRATION 10MG/ML) SO THAT CT SCAN AND INTUBATION CAN BE PERFORMED. WHILE ON SEDATION, THE PATIENT WAS FOUND TO BE HYPOTENSIVE (BLOOD PRESSURE DECREASED FROM 183/120 TO 60S/30S). IT IS UNCLEAR WHEN INFUSION INCREASED. IT WAS DOCUMENTED TO HAVE BEEN FOUND RUNNING AT 75 MCG/KG/MIN AT TIME OF HYPOTENSION. THE INFUSION WAS STOPPED BUT BLOOD PRESSURE DID NOT IMPROVE, REQUIRING VASOPRESSOR SUPPORT (LEVOPHED WAS STARTED). ALTHOUGH BLOOD PRESSURE IMPROVED, THE PATIENT FOUND TO HAVE AN ABSENT BRAINSTEM REFLEXES. THE PATIENT NEVER REGAINED CONSCIOUSNESS AND SUBSEQUENTLY EXPIRED. THE PATIENT'S FAMILY ALLEGES THAT THERE WAS AN ERROR IN THE INFUSION PROGRAMMING. HOWEVER, THE HOSPITAL DOES NOT BELIEVE THAT THERE WAS A PUMP MALFUNCTION NOR A DEVICE PROGRAMMING ERROR AND THAT THE CAUSE OF THE HYPOTENSION WAS DUE TO THE PATIENT'S EXISTING MEDICAL CONDITION ACCORDING TO THEIR PHYSICIANS.
IT WAS REPORTED THAT AN IMMUNOCOMPROMISED PATIENT WITH MENTAL STATUS CHANGES AND SUSPECTED MENINGITIS WAS BEING SEDATED WITH PROPOFOL THROUGH INFUSION PUMP (100ML BOTTLE, CONCENTRATION 10MG/ML) SO THAT CT SCAN AND INTUBATION CAN BE PERFORMED. WHILE ON SEDATION, THE PATIENT WAS FOUND TO BE HYPOTENSIVE (BLOOD PRESSURE DECREASED FROM 183/120 TO 60S/30S). IT IS UNCLEAR WHEN INFUSION INCREASED. IT WAS DOCUMENTED TO HAVE BEEN FOUND RUNNING AT 75 MCG/KG/MIN AT TIME OF HYPOTENSION. THE INFUSION WAS STOPPED BUT BLOOD PRESSURE DID NOT IMPROVE, REQUIRING VASOPRESSOR SUPPORT (LEVOPHED WAS STARTED). ALTHOUGH BLOOD PRESSURE IMPROVED, THE PATIENT FOUND TO HAVE AN ABSENT BRAINSTEM REFLEXES. THE PATIENT NEVER REGAINED CONSCIOUSNESS AND SUBSEQUENTLY EXPIRED. THE PATIENT'S FAMILY ALLEGES THAT THERE WAS AN ERROR IN THE INFUSION PROGRAMMING. HOWEVER, THE HOSPITAL DOES NOT BELIEVE THAT THERE WAS A PUMP MALFUNCTION NOR A DEVICE PROGRAMMING ERROR AND THAT THE CAUSE OF THE HYPOTENSION WAS DUE TO THE PATIENT'S EXISTING MEDICAL CONDITION ACCORDING TO THEIR PHYSICIANS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1680848 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8015 | 10885403810015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Female | Death | 8015| 8015(2)| 8100 |