FDA Adverse Event
Malfunction
Summary report: N
CRYOMACS FREEZING BAG 750
MDR report key: 6443473
·
Received March 29, 2017
Report
- Report Number
- 3005290010-2017-00008
- Event Type
- Malfunction
- Date Received
- March 29, 2017
- Date of Event
- August 2, 2016
- Report Date
- March 28, 2017
- Manufacturer
- MILTENYI BIOTEC GMBH
- Product Code
- LPZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED TO THE MANUFACTURER.
Description of Event or Problem · 1
THE OVERVRRAP BAG BURST WHEN BAG WAS PLACED IN THE VAPOR PHASE OF LIQUID NITROGEN PRIOR TO REMOVAL FROM THE STORAGE TANK AND THE CRYCMACS© FREEZING BAG 750 LEAKED THROUGH THE SEAL WHILE THAVRING IN V/ATER AT 38 C. THE CUSTOMER STATED THAT SUFFICIENT CELL AMOUNT WAS AVAILABLE FOR TRANSPLANTATION. THEREFORE, ANY RISK FOR THE PATIENT COULD BE RULED OUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 226792 | CRYOMACS FREEZING BAG 750 | CRYOMACS FREEZING BAG 750 | LPZ | MILTENYI BIOTEC GMBH | N/A | 6151027008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |