MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-18 for CRYOMACS FREEZING BAGS 500 N/A 200-074-402 manufactured by Miltenyi Biotec Gmbh.
[139199266]
The bag was stored directly in liquid nitrogen. So it's highly likely that liquid nitrogen entered the cryomacs bag through an insufficient welding seam and expanded after removal from this tank for thawing. If a bag is stored in the liquid phase of nitrogen it is recommended to place the bag into the vapor phase of nitrogen for a minimum of 4 hours before removal from the nitrogen tank and thawing. This is the second complaint regarding a breakage for this lot with a complaint rate of (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[139199267]
After removal from the liquid nitrogen tank and transport to the transplantation unit in liquid nitrogen, the overwrap bag expanded rapidly upon removal, which could be seen as an overwrap bubble protruding from the cassette- window. Upon opening of the cassette, the overwrap bag burst and the product was found to be ripped in two halves. The patient received a backup product for transplantation. For a potentially necessary second therapy no backup product would be available anymore.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005290010-2019-00001 |
| MDR Report Key | 8427585 |
| Date Received | 2019-03-18 |
| Date of Report | 2019-03-14 |
| Date of Event | 2019-02-15 |
| Date Mfgr Received | 2019-02-18 |
| Date Added to Maude | 2019-03-18 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. BETTINA-JUDITH H |
| Manufacturer Street | FRIEDRICH-EBERT-STR. 68 |
| Manufacturer City | BERGISCH GLADBACH, 51429 |
| Manufacturer Country | GM |
| Manufacturer Postal | 51429 |
| Manufacturer G1 | MILTENYI BIOTEC GMBH |
| Manufacturer Street | FRIEDRICH-EBERT-STR. 68 |
| Manufacturer City | BERGISCH GLADBACH, 51429 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 51429 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CRYOMACS FREEZING BAGS 500 |
| Generic Name | CRYOMACS FREEZING BAGS 500 |
| Product Code | KSR |
| Date Received | 2019-03-18 |
| Model Number | N/A |
| Catalog Number | 200-074-402 |
| Lot Number | 6180828034 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MILTENYI BIOTEC GMBH |
| Manufacturer Address | FRIEDRICH-EBERT-STR. 68 BERGISCH GLADBACH, 51429 GM 51429 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-18 |