FDA Adverse Event
Other
Summary report: N
CRYOCYTE FREEZING CONTAINER
MDR report key: 509973
·
Received January 12, 2004
Report
- Report Number
- 6000001-2003-09468
- Event Type
- Other
- Date Received
- January 12, 2004
- Date of Event
- December 9, 2003
- Report Date
- December 15, 2003
- Manufacturer
- BAXTER HEALTHCARE CORP.
- Product Code
- KSE
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
CRACK WAS DETECTED WHILE THAWING A CRYOCYTE FREEZING CONTAINER. VERY SMALL LEAKAGES AT THE SEAL WERE OBSERVED. PRODUCT WAS TRANSFERRED TO ANOTHER BAG AND TRANSPLANTED. AS A RESULT, THE PT WAS GIVEN ADDITIONAL ANTIBIOTIC THERAPY WITH TAGOZYT TALKOPLANIN AND CEFROTAXIN. PT WAS SUCCESSFULLY ENGRAFTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRYOCYTE FREEZING CONTAINER | CRYOCYTE FREEZING CONTAINER | KSE | BAXTER HEALTHCARE CORP. | NA | H02I03102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Other |