FDA Adverse Event
Malfunction
Summary report: N
ACCESS
MDR report key: 3173351
·
Received June 17, 2013
Report
- Report Number
- 1416980-2013-15581
- Event Type
- Malfunction
- Date Received
- June 17, 2013
- Date of Event
- May 21, 2013
- Report Date
- May 23, 2013
- Manufacturer
- BAXTER HEALTHCARE - AIBONITO
- Product Code
- FPB
- PMA / PMN Number
- K113227
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). SHOULD THE DEVICE OR ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE ADMINISTRATION OF TPN THE FILTERS OF A 3 LEAD EXTENSION SET WITH 0.22 MICRON AIR ELIMINATING FILTER BECAME DISCOLORED (TURNING EITHER BROWN OR BLACK). THIS OCCURRED DURING PATIENT INFUSION. 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 |
|---|---|---|---|---|---|---|---|
| 273835 | ACCESS | FILTER, INFUSION LINE | FPB | BAXTER HEALTHCARE - AIBONITO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | TPN SOLUTION |