FDA Adverse Event
Malfunction
Summary report: N
8110 ALARIS SYRINGE PUMP
MDR report key: 11070111
·
Received December 23, 2020
Report
- Report Number
- 2016493-2020-79851
- Event Type
- Malfunction
- Date Received
- December 23, 2020
- Report Date
- September 11, 2019
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403424267
- PMA / PMN Number
- K133532
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(4) WAS PERFORMED FROM THE DATE OF THE MANUFACTURE TO DATE OF THE RELEASE OF PRODUCT, WHICH CONFIRMED THAT THIS DEVICE WAS INVOLVED IN A PRODUCTION FAILURE, AND PRODUCT WAS RETURNED FOR SERVICING WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A TRACKWISE COMPLAINT HISTORY REVIEW WAS COMPLETED, AND IT WAS CONFIRMED THAT THERE WERE ADDITIONAL COMPLAINTS RECEIVED WITH SIMILAR SN (B)(4) FOR THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.
Description of Event or Problem · 1
ERROR CODE 13-1043-199/PLUNGER SLIPS- (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1534636 | 8110 ALARIS SYRINGE PUMP | PUMP, INFUSION | FRN | CAREFUSION SD | 8110 | 10885403424267 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |