MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-04 for CRYOMACS FREEZING BAG 50 200-074-400 manufactured by Miltenyi Biotec Gmbh.
[23536349]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005290010-2015-00001 |
| MDR Report Key | 4964923 |
| Date Received | 2015-08-04 |
| Date of Report | 2015-06-01 |
| Date of Event | 2015-02-12 |
| Date Mfgr Received | 2015-06-01 |
| Device Manufacturer Date | 2012-12-01 |
| Date Added to Maude | 2015-08-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NANCY JOHANSEN |
| Manufacturer Street | 85 HAMILTON ST., |
| Manufacturer City | CAMBRIDGE MA 02139 |
| Manufacturer Country | US |
| Manufacturer Postal | 02139 |
| Manufacturer Phone | 6172180062 |
| Manufacturer G1 | MILTENYI BIOTEC GMBH |
| Manufacturer Street | FRIEDRICHEBERTSTRASSE 68 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CRYOMACS FREEZING BAG 50 |
| Generic Name | CRYOMACS FREEZING BAG 50 |
| Product Code | KSR |
| Date Received | 2015-08-04 |
| Returned To Mfg | 2015-06-25 |
| Model Number | FREEZING BAG 50 |
| Catalog Number | 200-074-400 |
| Lot Number | 6121128005 |
| Device Expiration Date | 2015-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MILTENYI BIOTEC GMBH |
| Manufacturer Address | FRIEDRICHEBERTSTRASSE 68 BERGISCH GLADBACH GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-04 |