ALARIS PUMP MODULE
Report
- Report Number
- 2016493-2021-23110
- Event Type
- Malfunction
- Date Received
- February 4, 2021
- Report Date
- February 2, 2021
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- PMA / PMN Number
- K133532
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED. TECHNICAL SUPPORT PERFORMED TROUBLESHOOTING OVER THE PHONE TO DETERMINE THE CUSTOMER REPORTED ISSUE OF 8100 ERROR CODE 13-1033-149. BASED ON THE FINDINGS, TECHNICAL SUPPORT WAS UNABLE TO DETERMINE THE PROXIMATE CAUSE OF THE REPORTED ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 12/04/2007. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD WAS PERFORMED, WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER.
TECHNICAL SUPPORT PERFORMED TROUBLESHOOTING OVER THE PHONE TO DETERMINE THE CUSTOMER REPORTED ISSUE OF 8100 ERROR CODE 13-1033-149 TECHNICAL SUPPORT. REFLASH SOFTWARE. REPLACE LOGIC BOARD. RETURN THE MODULE TO THE FACTORY. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 12/04/2007. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(6) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS INVOLVED IN A PRODUCTION FAILURE. Q6 200072997 H3 OTHER TEXT : DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.
THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED. TECHNICAL SUPPORT PERFORMED TROUBLESHOOTING OVER THE PHONE TO DETERMINE THE CUSTOMER REPORTED ISSUE OF 8100 ERROR CODE 13-1033-149. BASED ON THE FINDINGS, TECHNICAL SUPPORT WAS UNABLE TO DETERMINE THE PROXIMATE CAUSE OF THE REPORTED ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 12/04/2007. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD WAS PERFORMED, WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER.
IT WAS REPORTED THAT THE DEVICE HAD ERROR CODE 13-1033-149. NO PATIENT INVOLVEMENT.
IT WAS REPORTED THAT THE DEVICE HAD ERROR CODE 13-1033-149. NO PATIENT INVOLVEMENT.
IT WAS REPORTED THAT THE DEVICE HAD ERROR CODE 13-1033-149. NO PATIENT INVOLVEMENT.
THE DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION
IT WAS REPORTED THAT THE DEVICE HAD ERROR CODE 13-1033-149. NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 178888 | ALARIS PUMP MODULE | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |