MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-27 for 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER CF-250 manufactured by Charter Medical, Ltd..
[106981499]
The reported leak occurred during the thawing process at the user's facility. The leak did not occur during filling of the bag, which suggests the leak likely did not exist before the bag was frozen. A single sample was received for investigation. The sample contained a spike component in the left spike port. Visual inspection revealed a tear in the film, directly under the end of right spike port tube. The opening was approximately 1/2-inch long. Additionally, there appeared to be label adhesive residue on the bag (opposite side from there the film tear was located). It is unknown if an adhesive label may have contributed to the film tear observed on the sample. An adhesive label could potentially interfere with the flexible characteristics of the film, possibly resulting in the crack/tear observed from the bag photos provided by the user. The root cause of the film tear on the bag could not be conclusively determined and the exact point in the process where the film tear occurred is unknown. 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. Precautions for potential issues addressed above are addressed in the product ifu's.
Patient Sequence No: 1, Text Type: N, H10
[106981500]
The end user experienced a bag break (film tore near the base of a port) of a cf-250 bag. The cf-250 device contained approximately 70ml of cell product. The break was observed when the bag was being thawed. The cell product was transferred to another bag and infused into a 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 | 1066733-2018-00009 |
| MDR Report Key | 7467973 |
| Date Received | 2018-04-27 |
| Date of Report | 2018-04-23 |
| Date of Event | 2018-03-27 |
| Date Mfgr Received | 2018-03-27 |
| Device Manufacturer Date | 2017-12-02 |
| Date Added to Maude | 2018-04-27 |
| 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 | 2018-04-27 |
| Returned To Mfg | 2018-04-13 |
| Model Number | CF-250 |
| Catalog Number | CF-250 |
| Lot Number | 151496 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-04-27 |