FDA Adverse Event
Malfunction
Summary report: N
ACCESS
MDR report key: 3830758
·
Received May 23, 2014
Report
- Report Number
- 1416980-2014-16845
- Event Type
- Malfunction
- Date Received
- May 23, 2014
- Report Date
- April 30, 2014
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- FPA
- PMA / PMN Number
- K961225
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ROLLER CLAMP OF A CLEARLINK CONTINU-FLO SOLUTION SET WAS ¿DOWN¿ DURING INFUSION, LEADING TO AN OVERINFUSION OF ANTIBIOTICS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 308125 | ACCESS | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |