FDA Adverse Event
Malfunction
Summary report: N
ACCESS
MDR report key: 3885244
·
Received June 19, 2014
Report
- Report Number
- 1416980-2014-19533
- Event Type
- Malfunction
- Date Received
- June 19, 2014
- Report Date
- May 22, 2014
- Manufacturer
- BAXTER HEALTHCARE - AIBONITO
- Product Code
- FPA
- PMA / PMN Number
- K121634
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION AND THE LOT NUMBER IS UNKNOWN. THEREFORE, NO ANALYSIS CAN BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO REGULATOR DISCONNECTED. THIS OCCURRED WHILE FLUSHING THE LINE DURING INFUSION OF 0.9% NORMAL SALINE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 361521 | ACCESS | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE - AIBONITO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 500CC 0.9% NORMAL SALINE |