8015 ALARIS SYSTEM PC UNIT
Report
- Report Number
- 2016493-2022-1179037
- Event Type
- Malfunction
- Date Received
- December 26, 2022
- Report Date
- October 20, 2019
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403801518
- PMA / PMN Number
- K133532
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITION: UPDATED ADVERSE EVENT CODES (H6).
NOTE: THIS EVENT WAS INADVERTENTLY REPORTED UNDER INCORRECT PRODUCT REGISTRATION NUMBER (MANUFACTURER REPORT NUMBER 9616066-2020-02923). THIS MDR RESUBMISSION NOW REFLECTS THE CORRECT PRODUCT REGISTRATION NUMBER. THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED. THE DEVICE WAS REPAIRED, RETESTED AND RETURNED TO THE CUSTOMER. INFUSION PRODUCTS GLOBAL CUSTOMER SUPPORT OPERATIONS. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN 13835043 WAS PERFORMED FROM THE DATE OF THE MANUFACTURE TO DATE OF THE RELEASE OF PRODUCT, WHICH CONFIRMED THAT THIS DEVICE WAS NOT 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.
UNIT DUE FOR 2YR BATTERY CHANGE- 10/20/2019 20:39:53 (B)(6) - UNIT DUE FOR 2YR BATTERY CHANGE THERE WAS NO PATIENT INVOLVEMENT.
UNIT DUE FOR 2YR BATTERY CHANGE- 10/20/2019 20:39:53 VICTOR CABRERA (VCABRERA) - UNIT DUE FOR 2YR BATTERY CHANGE. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 441911 | 8015 ALARIS SYSTEM PC UNIT | PUMP, INFUSION | FRN | CAREFUSION SD | 8015 ALARIS PCU 1.5 MODULE | 10885403801518 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |