FDA Adverse Event
Other
Summary report: N
SEPACELL PRE-STORAGE LEUKOCYTE REDUCTION SET
MDR report key: 300550
·
Received October 12, 2000
Report
- Report Number
- 9612051-2000-00016
- Event Type
- Other
- Date Received
- October 12, 2000
- Date of Event
- September 15, 2000
- Report Date
- October 11, 2000
- Manufacturer
- BAXTER HEALTHCARE CORP
- Product Code
- CAK
- Removal / Correction Number
- 1420141-09-18-2000-001-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
DURING THE INVESTIGATION PROCESS, A BAXTER REP VISITED THIS CUSTOMER IN 2000. WHILE AT THIS FACILITY THE REP NOTED ALTERNATING SEGMENTS OF BLOOD AND AIR IN THE POST FILTRATION TUBING ON TWO FILTER SETS OF THE 4C2300. AS NO VISIBLE BLOOD LEAK WAS OBSERVED, THESE TWO FILTER SETS WERE RETURNED TO BAXTER FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SEPACELL PRE-STORAGE LEUKOCYTE REDUCTION SET | SEPACELL PRE-STORAGE LEUKOCYTE REDUCTION SET | CAK | BAXTER HEALTHCARE CORP | NA | A00H02017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |