FDA Adverse Event
Malfunction
Summary report: N
CRYOMACS FREEZING BAG 50
MDR report key: 4964923
·
Received August 4, 2015
Report
- Report Number
- 3005290010-2015-00001
- Event Type
- Malfunction
- Date Received
- August 4, 2015
- Date of Event
- February 12, 2015
- Report Date
- June 1, 2015
- Manufacturer
- MILTENYI BIOTEC GMBH
- Product Code
- KSR
- PMA / PMN Number
- BK090020
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
WHEN THE CUSTOMER PULLED ONE CRYOMACS FREEZING BAG 50 OUT OF THE LIQUID NITROGEN TANK THE OVERWRAP BAG HAD CRACKED. DURING THAWING THE CUSTOMER NOTED A BLOOD LEAKAGE ON THE RIGHT LOWER CORNER OF THE CRYOMACS FREEZING BAG 50. CONSEQUENTLY, THE CUSTOMER LOST THE CELLULAR PRODUCT WHICH WAS PART OF A MASTER CELL BANK FOR PLASMACYTOID DENDRITIC CELLS CONSISTING OF 385 BAGS IN TOTAL. BASED ON THE INFORMATION PROVIDED SO FAR IT CAN BE STATED THAT THERE IS NO HARM FOR THE PATIENTS BECAUSE THERE ARE STILL 384 BAGS LEFT INTACT. THE EVENT HAPPENED AT: (B)(6). SEE SCANNED PAGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 509409 | CRYOMACS FREEZING BAG 50 | CRYOMACS FREEZING BAG 50 | KSR | MILTENYI BIOTEC GMBH | FREEZING BAG 50 | 6121128005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |