FDA Adverse Event
Malfunction
Summary report: N
CRYOCYTE FREEZING CONTAINER 500 ML W/LABEL POCKET
MDR report key: 1071541
·
Received July 3, 2008
Report
- Report Number
- 1423500-2008-00593
- Event Type
- Malfunction
- Date Received
- July 3, 2008
- Date of Event
- June 12, 2008
- Report Date
- June 16, 2008
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- KSE
- PMA / PMN Number
- BK950049
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THIS IS A REPORT RECEIVED BY THE DISTRIBUTOR, IN OTHER COUNTRY. A CRACK ON THE CRYOCYTE CONTAINER OCCURRED AFTER REMOVAL FROM THE STORAGE TANK. DUE TO THIS EVENT 0.75X10E6/KG CD34 POSITIVE STEM CELLS WERE LOST. FORTUNATELY, BACKUP CONTAINERS WERE FROZEN, SO THAT AT LEAST 2.25X10E6/KG C34+ CELLS WERE AVAILABLE FOR INFUSION. THERE WAS NO PT INJURY. IF ANY ADDITIONAL INFO SHOULD BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRYOCYTE FREEZING CONTAINER 500 ML W/LABEL POCKET | 81KSE | KSE | BAXTER HEALTHCARE | H02J17036 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |