ALARIS SYSTEM
Report
- Report Number
- 2016493-2021-55700
- Event Type
- Death
- Date Received
- July 16, 2021
- Date of Event
- May 10, 2021
- Report Date
- March 24, 2022
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403801518
- PMA / PMN Number
- K133532
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
(B)(4).
(B)(4). A REVIEW OF THE COMPLAINT HISTORY FOR THIS SERIALIZED UNIT DID NOT CONFIRM SIMILAR COMPLAINTS, BASED ON THE SAME OR RELATED FAILURE MODE FOR THIS EVENT. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE.
IT WAS REPORTED THAT THERE WAS A SUSPICIOUS DEATH AT THE MEDICAL CENTER INVOLVING INFUSION PUMPS THAT WERE ALLEGEDLY BEING PAUSED.
IT WAS REPORTED THAT THERE WAS A SUSPICIOUS DEATH AT THE MEDICAL CENTER INVOLVING INFUSION PUMPS THAT WERE ALLEGEDLY BEING PAUSED.
INITIAL REPORTER ADDR 1 IS UNKNOWN. INITIAL REPORTER FACILITY NAME: (B)(6) VETERANS AFFAIRS MEDICAL CENTER. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.
IT WAS REPORTED THAT THERE WAS A SUSPICIOUS DEATH AT THE MEDICAL CENTER INVOLVING INFUSION PUMPS THAT WERE ALLEGEDLY BEING PAUSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1080767 | ALARIS SYSTEM | INFUSION PUMP | FRN | CAREFUSION SD | 8015 | 10885403801518 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Death | 8100(4)| 8100(4) |