ALARIS SYSTEM PC UNIT
Report
- Report Number
- 2016493-2021-29129
- Event Type
- Malfunction
- Date Received
- February 26, 2021
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403801518
- PMA / PMN Number
- K133532
- Removal / Correction Number
- Z-2909-2020, Z-2717-2020
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
ADDITIONAL INFORMATION:E2, D9, G2(REPORT SOURCE), H3, H6. A REVIEW OF THE COMPLAINT HISTORY RECORD WAS PERFORMED FOR THE SN (B)(6) WHICH CONFIRMED SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 21NOV2018. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD FOR (B)(6) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE.
THIS DEVICE WAS EVALUATED AND REPAIRED THROUGH THE SERVICE REPAIR PROCESS. UPON VISUAL INSPECTION THE SERVICE TECHNICIAN NOTED THAT THEY DETECTED ERROR CODES 100.6070 AND 110.5020, REFLASHED POLO SOFTWARE AND REPLACED FAILED RTC BATTERY ON THE LOGIC BOARD, CORRODED LEFT/RIGHT IUIS, UNRESPONSIVE KEYPAD. THIS DEVICE IS BEING RETURNED WITH THE NON-STANDARD BATTERY REMOVED, BECAUSE THIS BATTERY HAS NOT BEEN APPROVED FOR USE IN THIS DEVICE. THE DEVICE HAS BEEN TESTED WITH AN ALARIS PRODUCTS-APPROVED BATTERY. PLEASE USE ONLY BATTERIES APPROVED BY CAREFUSION ALARIS PRODUCTS, DUE TO BATTERY MANAGER REQUIREMENTS AND THE THERMOSTAT CONTAINED IN THE BATTERY ASSEMBLY. THE USE OF NON-STANDARD BATTERIES MAY NEGATIVELY IMPACT THE PERFORMANCE OF THE DEVICES AND MAY VOID THE WARRANTY. BATTERY REPLACEMENT SHOULD BE PERFORMED ONLY BY QUALIFIED SERVICE PERSONNEL WHILE THE INSTRUMENT IS NOT IN USE. PLEASE REFER TO THE DISASSEMBLY/REASSEMBLY SECTION OF THE SERVICE MANUAL FOR BATTERY INSTALLATION INSTRUCTIONS. THE FAILURE CODE OTHER WAS USED TO TRACK THE ALARIS PUMP SOFTWARE VERSION AS RECEIVED FROM THE CUSTOMER AND THE SOFTWARE VERSION WHEN DEVICE WAS SENT BACK TO THE CUSTOMER. IT DOES NOT REFLECT A DEVICE FAILURE OR REPRESENT ANY RISK TO THE PATIENT. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 21NOV2018. 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 (B)(6) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. BASED ON THE FINDINGS, SERVICE DETERMINED THAT THE PROBABLE ROOT CAUSE OF THE REPORTED ISSUE WAS DUE TO THE ELECTRICAL FAILURE OF THE LOGIC BOARD-CIRCUIT FAILURE. A REVIEW OF THE COMPLAINT HISTORY RECORD IN TRACKWISE AND SAP WAS PERFORMED FOR THE SN (B)(6) WHICH CONFIRMED SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER.
THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.
IT WAS REPORTED BY THE CUSTOMER THAT THE DEVICE GAVE 11.5020 ERROR CODE AND RESET DATE TO (B)(6) 2000.
IT WAS REPORTED BY THE CUSTOMER THAT THE DEVICE GAVE 11.5020 ERROR CODE AND RESET DATE TO 2000-01-01. THERE WAS NO PATIENT INVOLVEMENT.
IT WAS REPORTED BY THE CUSTOMER THAT THE DEVICE GAVE 11.5020 ERROR CODE AND RESET DATE TO 2000-01-01.
ALTHOUGH REQUESTED, 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 BY THE CUSTOMER THAT THE DEVICE GAVE 11.5020 ERROR CODE AND RESET DATE TO 2000-01-01.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 281878 | ALARIS SYSTEM PC UNIT | PUMP, INFUSION | FRN | CAREFUSION SD | 8015 | 10885403801518 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |