MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-24 for 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER CF-250 manufactured by Charter Medical, Ltd..
[109518072]
The complaint sample, or pictures of the complaint device, was not returned to the manufacturer for investigation/review. The reported leak did not occur during filling of the bag, which suggests the leak likely occurred during handling after the bag was frozen. There was no additional information to suggest an exact root cause for this report. There are several potential issues which could contribute to a failure mode of this nature: residual moisture on the outside of the bag when it was placed inside the cassette. Residual moisture could cause the bag to freeze/adhere to the cassette during the freezing process. A condition of this type could cause film damage upon removal of a frozen bag from the cassette. Handling of the bag in the frozen state. The film of a frozen bag is fragile - inadvertent manipulation or impact on the bag could cause the film to fracture. The precautions indicated above are addressed in the product ifu's.
Patient Sequence No: 1, Text Type: N, H10
[109518073]
The end user experienced a leak from a possible film tear in a cf-250 device while the bag was being thawed. The cell product was infused into the patient. A sterility sample was also taken from the cell product in the bag. The sterility test was negative for growth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1066733-2018-00010 |
| MDR Report Key | 7542103 |
| Date Received | 2018-05-24 |
| Date of Report | 2018-05-24 |
| Date of Event | 2018-04-24 |
| Date Mfgr Received | 2018-04-24 |
| Device Manufacturer Date | 2017-12-02 |
| Date Added to Maude | 2018-05-24 |
| 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 | MS. JESSICA HUGHES |
| Manufacturer Street | 3948-A WESTPOINT BLVD. |
| Manufacturer City | WINSTON SALEM NC 27103 |
| Manufacturer Country | US |
| Manufacturer Postal | 27103 |
| Manufacturer Phone | 3367686447 |
| Manufacturer G1 | CHARTER MEDICAL, LTD. |
| Manufacturer Street | 3948-A WESTPOINT BLVD. |
| Manufacturer City | WINSTON SALEM NC 27103 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27103 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER |
| Generic Name | 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER |
| Product Code | LPZ |
| Date Received | 2018-05-24 |
| Model Number | CF-250 |
| Catalog Number | CF-250 |
| Lot Number | 151496 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHARTER MEDICAL, LTD. |
| Manufacturer Address | 3948-A WESTPOINT BLVD. WINSTON SALEM NC 27103 US 27103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-24 |