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 500 200-074-402 manufactured by Miltenyi Biotec Gmbh.
[23475467]
Method: device not returned, method consisted of analysis of cryomacs complaint questionnaire with detailed thawing description. Results of the investigation are attached to this mdr.
Patient Sequence No: 1, Text Type: N, H10
[23475468]
The customer reported that the overwrap bags of three cryomacs freezing bags 500 were swelling up on the third day of freezing and thus the bags could not be taken out of the cassette used for storage in the vapor phase of liquid nitrogen. Based on the information provided so far it is unclear whether or not the patient received sufficient cell amount. Therefore a potential harm for the patient cannot be ruled out at this time point. The event happened at (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005290010-2015-00002 |
| MDR Report Key | 4964921 |
| Date Received | 2015-08-04 |
| Date of Report | 2015-06-03 |
| Date Mfgr Received | 2015-06-03 |
| Device Manufacturer Date | 2012-10-01 |
| 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 |
| 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 500 |
| Generic Name | CRYOMACS FREEZING BAG 500 |
| Product Code | KSR |
| Date Received | 2015-08-04 |
| Model Number | FREEZING BAG 500 |
| Catalog Number | 200-074-402 |
| Lot Number | 6120924008 |
| Device Expiration Date | 2015-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MILTENYI BIOTEC GMBH |
| Manufacturer Address | FRIEDRICHEBERTSTRASSE 68 BERGISCH GLADBACH 51429 GM 51429 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-04 |