FDA Adverse Event
Injury
Summary report: N
ALARIS SYSTEM
MDR report key: 14187083
·
Received April 22, 2022
Report
- Report Number
- 2016493-2022-134588
- Event Type
- Injury
- Date Received
- April 22, 2022
- Date of Event
- March 31, 2022
- Report Date
- May 9, 2022
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810015
- PMA / PMN Number
- K133532
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
INITIAL REPORTER ADDR: (B)(6). BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.
Description of Event or Problem · 0
IT WAS REPORTED THAT A PUMP MODULE WAS PROGRAMED FOR A PROPOFOL INFUSION. CLINICIAN IS NOTED AT SOME POINT THE INFUSION BEGAN FREE FLOWING. THERE WAS PATIENT INVOLVEMENT AND PATIENT HARM.
Description of Event or Problem · 0
IT WAS REPORTED THAT A PUMP MODULE WAS PROGRAMED FOR A PROPOFOL INFUSION. CLINICIAN IS NOTED AT SOME POINT THE INFUSION BEGAN FREE FLOWING. THERE WAS PATIENT INVOLVEMENT AND PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1272620 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention | 8015| 8100(2) |