ALARIS SYSTEM
Report
- Report Number
- 2016493-2022-144338
- Event Type
- Injury
- Date Received
- May 13, 2022
- Date of Event
- May 28, 2020
- Report Date
- September 28, 2022
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403222054
- PMA / PMN Number
- K133532
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
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.
CORRECTION : ADVERSE TYPE, UNIQUE IDENTIFIER (UDI) #, TYPE OF REPORTABLE EVENTS, IMDRF ANNEX F CODES. 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: A140504 - INACCURATE DELIVERY (2339). CORRECTION: DATE OF EVENT, DESCRIBE EVENT OR PROBLEM, CONCOMITANT MED PROD DATA, INITIAL REPORTER ADDR 1, INITIAL REPORTER CITY, IMDRF ANNEX A CODE. ADDITIONAL INFORMATION: INITIAL REPORTER ZIP.
ADDITIONAL INFORMATION: IMDRF ANNEX A,G CODES.
A REPORT WAS RECEIVED FROM HEALTH CANADA REGARDING AN EVENT THAT WAS SUBMITTED BY THE USER FACILITY TO THE CANADA VIGILANCE PROGRAM. THE REPORT DID NOT HAVE THE DETAILS OF THE EVENT. HOWEVER, IT CONTAINS THE FOLLOWING IMDRF CODES: (B)(4). THERE WAS PATIENT INVOLVEMENT.
THERE WAS PATIENT INVOLVEMENT.
A REPORT WAS RECEIVED FROM HEALTH CANADA REGARDING AN EVENT THAT WAS SUBMITTED BY THE USER FACILITY TO THE CANADA VIGILANCE PROGRAM. THE REPORT DID NOT HAVE THE DETAILS OF THE EVENT. HOWEVER, IT CONTAINS THE FOLLOWING IMDRF CODES: A14 - INFUSION OR FLOW PROBLEM. A140304 - VOLUME ACCURACY PROBLEM. F26 - NO HEALTH CONSEQUENCES OR IMPACT. B17 - DEVICE NOT RETURNED. E2401 - INSUFFICIENT INFORMATION. C20 - NO FINDINGS AVAILABLE. D15 - CAUSE NOT ESTABLISHED. THERE WAS PATIENT INVOLVEMENT. A REPORT WAS RECEIVED FROM HEALTH CANADA'S CANADA VIGILANCE PROGRAM WHICH STATES,"MEDICATION INFUSED TOO QUICKLY." THERE WAS NO INFORMATION ON PATIENT IMPACT.
A REPORT WAS RECEIVED FROM HEALTH CANADA REGARDING AN EVENT THAT WAS SUBMITTED BY THE USER FACILITY TO THE CANADA VIGILANCE PROGRAM. THE REPORT DID NOT HAVE THE DETAILS OF THE EVENT. HOWEVER, IT CONTAINS THE FOLLOWING IMDRF CODES: A14 - INFUSION OR FLOW PROBLEM A140304 - VOLUME ACCURACY PROBLEM F26 - NO HEALTH CONSEQUENCES OR IMPACT B17 - DEVICE NOT RETURNED E2401 - INSUFFICIENT INFORMATION C20 - NO FINDINGS AVAILABLE D15 - CAUSE NOT ESTABLISHED THERE WAS PATIENT INVOLVEMENT. A REPORT WAS RECEIVED FROM HEALTH CANADA'S CANADA VIGILANCE PROGRAM WHICH STATES,"MEDICATION INFUSED TOO QUICKLY." THERE WAS NO INFORMATION ON PATIENT IMPACT.
A REPORT WAS RECEIVED FROM HEALTH CANADA REGARDING AN EVENT THAT WAS SUBMITTED BY THE USER FACILITY TO THE CANADA VIGILANCE PROGRAM. THE REPORT DID NOT HAVE THE DETAILS OF THE EVENT. HOWEVER, IT CONTAINS THE FOLLOWING IMDRF CODES: A14 INFUSION OR FLOW PROBLEM. A140304 VOLUME ACCURACY PROBLEM. F26 NO HEALTH CONSEQUENCES OR IMPACT. B17 DEVICE NOT RETURNED. E2401 INSUFFICIENT INFORMATION. C20 NO FINDINGS AVAILABLE. D15 CAUSE NOT ESTABLISHED. THERE WAS PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2040380 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403222054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention | 8015| 8015 |