FDA Adverse Event
Malfunction
Summary report: N
ALARIS PUMP MODULE
MDR report key: 10962744
·
Received December 7, 2020
Report
- Report Number
- 2016493-2020-59723
- Event Type
- Malfunction
- Date Received
- December 7, 2020
- Report Date
- November 4, 2020
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- PMA / PMN Number
- K133532
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER REPORTED ISSUE WAS CONFIRMED. THE DEVICE WAS REPAIRED, PASSED ALL REQUIRE TESTING AND SPECIFICATIONS AND RELEASED BACK TO THE CUSTOMER. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(4) WAS PERFORMED FROM DATE OF MANUFACTURE 02/25/2005 TO THE PRESENT DATE (B)(6) 2020 AND CONFIRMED THAT THIS DEVICE WAS PREVIOUSLY RETURNED FOR SERVICING 1 TIME. DEVICE HAD NO SIMILAR SERVICE REPAIR HISTORY AND THERE WERE NO PRODUCTION FAILURES INDICATED ON THE SOURCE DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS BROKEN OR DAMAGED. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1427534 | ALARIS PUMP MODULE | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |