ALARIS SYSTEM
Report
- Report Number
- 2016493-2024-36915
- Event Type
- Malfunction
- Date Received
- September 19, 2024
- Date of Event
- August 27, 2024
- Report Date
- January 9, 2025
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403519284
- PMA / PMN Number
- K211218
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE HISTORY RECORD, COMPLAINT HISTORY REVIEW, AND RISK REVIEW ON FAILURE MODES ARE PERFORMED ON EACH DEVICE WITH REPORTABLE MALFUNCTION(S) ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. FIELD TECHNICIAN STATED ISSUE OF TAMPER SWITCH WAS CONFIRMED. ON 27-AUGUST-2024, PCU WAS RECEIVED UNBOXED AND WITH PAPERWORK. EXTERNAL INSPECTION REVEALED NO PHYSICAL DAMAGE, COSMETIC DAMAGE OR LABELING DAMAGE. THE STATED ISSUE OF TAMPER SWITCH BROKEN WAS CONFIRMED. RUNNING ASM KEYPAD TEST CONFIRMED TAMPER SWITCH NOT FUNCTIONING. THE TAMPER SWITCH WAS FUNCTIONING CORRECTLY. THE PROBLEM IS A BAD SIO BOARD (FIGURE 1). BAD SIO BOARD, DEFECTIVE MATERIAL FROM SUPPLIER. DEVICE TO BE RETURNED TO SAN DIEGO REPAIR CENTER FOR PROCESSING. RECOMMEND BD SAN DIEGO REPAIR CENTER REPLACE THE SIO BOARD. FAILURE INVESTIGATION REPORT ATTACHED TO QN IN SAP. THIS REPORT LISTS IMDRF ANNEX A, C, D, AND G CODES THAT ARE REPORTABLE MALFUNCTIONS OBSERVED ON THE DEVICE DURING SERVICING. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE.
A DEVICE HISTORY RECORD, COMPLAINT HISTORY REVIEW, AND RISK REVIEW ON FAILURE MODES ARE PERFORMED ON EACH DEVICE WITH REPORTABLE MALFUNCTION(S) ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. FIELD TECHNICIAN STATED ISSUE OF TAMPER SWITCH WAS CONFIRMED. ON 27-AUGUST-2024, PCU WAS RECEIVED UNBOXED AND WITH PAPERWORK. EXTERNAL INSPECTION REVEALED NO PHYSICAL DAMAGE, COSMETIC DAMAGE OR LABELING DAMAGE. THE STATED ISSUE OF TAMPER SWITCH BROKEN WAS CONFIRMED. RUNNING ASM KEYPAD TEST CONFIRMED TAMPER SWITCH NOT FUNCTIONING. THE TAMPER SWITCH WAS FUNCTIONING CORRECTLY. THE PROBLEM IS A BAD SIO BOARD (FIGURE 1). BAD SIO BOARD, DEFECTIVE MATERIAL FROM SUPPLIER. DEVICE TO BE RETURNED TO SAN DIEGO REPAIR CENTER FOR PROCESSING. RECOMMEND BD SAN DIEGO REPAIR CENTER REPLACE THE SIO BOARD. FAILURE INVESTIGATION REPORT ATTACHED TO QN IN SAP. THIS REPORT LISTS IMDRF ANNEX A, C, D, AND G CODES THAT ARE REPORTABLE MALFUNCTIONS OBSERVED ON THE DEVICE DURING SERVICING. PER 803.52(F)(11)(III). THE INFORMATION PROVIDED WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE.
A DEVICE HISTORY RECORD REVIEW IS PERFORMED ON EACH DEVICE REPORTED IN A MDR REPORTABLE EVENT ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE.
IT WAS REPORTED THAT THE DEVICE HAD TAMPER SWITCH NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.
IT WAS REPORTED THAT THE DEVICE HAD TAMPER SWITCH NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.
IT WAS REPORTED THAT THE DEVICE HAD TAMPER SWITCH NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1785381 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8015 | 10885403519284 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |