ALARIS SYSTEM
Report
- Report Number
- 2016493-2024-12179
- Event Type
- Malfunction
- Date Received
- February 2, 2024
- Date of Event
- December 20, 2023
- Report Date
- May 6, 2024
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403286186
- PMA / PMN Number
- K133532
- Removal / Correction Number
- Z-2719-2020
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 505
Narratives
A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER. H3 OTHER TEXT : DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.
ADDITIONAL INFORMATION: IMDRF ANNEX B CODE AND MANUFACTURER NARRATIVE. 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.
OMIT : B17 - DEVICE NOT RETURNED, C20 - NO FINDINGS AVAILABLE, D15 - CAUSE NOT ESTABLISHED. ADDITIONAL INFORMATION : DEVICE AVAILABLE FOR EVAL?, RETURNED TO MANUFACTURER ON, DEVICE EVAL BY MANUFACTURER?, IMDRF ANNEX A, G, B, C, D CODES, REMEDIAL ACTION REQUIRED AND REMEDIAL ACTION #.
IT WAS REPORTED THAT THE SYRINGE PUMP MODULE HAD AN OVER INFUSION OF HPN. THE TIME TO BE INFUSED WAS OVER 60 MINUTES, HOWEVER THE HPN INFUSED IN 1 MINUTE SHORT. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.
IT WAS REPORTED THAT THE SYRINGE PUMP MODULE HAD AN OVER INFUSION OF HPN. THE TIME TO BE INFUSED WAS OVER 60 MINUTES, HOWEVER THE HPN INFUSED IN 1 MINUTE SHORT. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.
IT WAS REPORTED THAT THE SYRINGE PUMP MODULE HAD AN OVER INFUSION OF HPN. THE TIME TO BE INFUSED WAS OVER 60 MINUTES, HOWEVER THE HPN INFUSED IN 1 MINUTE SHORT. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1621920 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8110 | 10885403286186 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | 8015. |