FDA Adverse Event
Malfunction
Summary report: N
CRYOCYTE, 50 ML W/LBL PKT.
MDR report key: 1418656
·
Received April 1, 2009
Report
- Report Number
- 1416980-2009-00015
- Event Type
- Malfunction
- Date Received
- April 1, 2009
- Date of Event
- March 4, 2009
- Report Date
- April 1, 2009
- Manufacturer
- BAXTER HEALTHCARE - MOUNTAIN HOME
- Product Code
- KSR
- PMA / PMN Number
- BK950049
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
AN ASSESSMENT OF THE CASE IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON ITS COMPLETION.
Description of Event or Problem · 1
THIS IS A REPORT RECEIVED BY BAXTER IN 2009, FROM A CUSTOMER. THE SAME DAY, THE CUSTOMER OBSERVED THAT ONE UNIT OF CRYOCYTE, 50 ML W/LBL PKT. (CODE R4R9951, BATCH H08E23045) SHOWED A STAR-SHAPED CRACK. THE BAG WAS FOUND IN THE MVE CRYO-PRESERVATION SYSTEM. THIS CRACK WAS NOT OBSERVED AFTER COMPUTER-CONTROLLED FREEZING. THE CUSTOMER PUT 7 ML IN THIS BAG. NO CLINICAL IMPACT ON THE PT AND/OR USER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRYOCYTE, 50 ML W/LBL PKT. | 81KSR | KSR | BAXTER HEALTHCARE - MOUNTAIN HOME | H08E23045 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |