FDA Adverse Event
Malfunction
Summary report: N
ACCESS
MDR report key: 4243868
·
Received November 11, 2014
Report
- Report Number
- 1416980-2014-39928
- Event Type
- Malfunction
- Date Received
- November 11, 2014
- Date of Event
- October 10, 2014
- Report Date
- October 17, 2014
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL FLOW TESTING WAS UNABLE TO RECREATE THE NO-FLOW. THE REPORTED CONDITION WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT SOLUTION DID NOT FLOW THROUGH THE FILTER OF AN INTERLINK EXTENSION SET. THIS OCCURRED DURING INFUSION. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 725428 | ACCESS | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE - SINGAPORE | SR11L21033 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |