MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-13 for 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER CF-250 manufactured by Charter Medical, Ltd..
[105901663]
The complaint sample was not returned to the manufacturer for investigation/review. However, two pictures of the bag were forwarded by the user facility. A crack in the film was observed from the picture. The crack appeared to be approximately 3/8-inch long and ran inside the top perimeter weld of the bag. The crack extended into the bag interior, which appears to be the source of the reported leak. A crack of the size observed in the picture would have been detected during 100% leak testing at charter medical. Additionally, a film crack of this nature would have likely occurred while the film was in a frozen state. The reported leak did not occur during filling of the bag, which suggests the leak likely occurred during handling after the bag was frozen. Cf-250 devices are 100% leak tested during the cml manufacturing process (validated leak test). Since the production leak test pressurizes the bag to 10 psi (constrained), a leak of the nature on the returned sample would have been detected with the manufacturing leak test if the leak existed at that time. 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. Precautions to help prevent issues indicated above are addressed in the product ifu's.
Patient Sequence No: 1, Text Type: N, H10
[105901664]
At the time of thawing the a blood and/or marrow transplant product; a breakage near the port was reported. The bag contained approximately 60 ml of cell material. The incident involved loss of some product and obviously a breach of sterility. There was a small crack visible on the bag. Tech called supervisor immediately. The contents of the bag were not infused into the patient. The bag was disposed of by the user facility. The exact date of the occurrence is not available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1066733-2018-00007 |
| MDR Report Key | 7430641 |
| Date Received | 2018-04-13 |
| Date of Report | 2018-04-11 |
| Date of Event | 2018-03-13 |
| Date Mfgr Received | 2018-03-13 |
| Device Manufacturer Date | 2017-08-23 |
| Date Added to Maude | 2018-04-13 |
| 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 | 2018-04-13 |
| Model Number | CF-250 |
| Catalog Number | CF-250 |
| Lot Number | 149938 |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 2018-04-13 |