FDA Adverse Event
Malfunction
Summary report: N
ACCESS
MDR report key: 3223530
·
Received July 12, 2013
Report
- Report Number
- 1416980-2013-18179
- Event Type
- Malfunction
- Date Received
- July 12, 2013
- Report Date
- June 19, 2013
- Manufacturer
- BAXTER HEALTHCARE - AIBONITO
- Product Code
- FPA
- PMA / PMN Number
- K120443
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A STANDARD BORE CATHETER EXTENSION SET EXPERIENCED A NO FLOW. THIS MALFUNCTION OCCURRED IN THE RADIOLOGY DEPARTMENT WHILE USING A NON-BAXTER RAPID INFUSER IN ATTEMPTS TO PUT A PATIENT UNDER ANESTHESIA. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 323940 | ACCESS | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE - AIBONITO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN RAPID INFUSER |