MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-22 for 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER CF-250 manufactured by Charter Medical, Ltd..
[100913040]
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. The cassette containing the bag was handled at the blood center during shipping preparation, and the cassette and bag was handled at the hospital. 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
[100913041]
A blood center customer reported they were made aware on (b)(6) 2018, from a hospital client, that one of their cell freeze ln2 freezing containers was broken. Phone conversations with laboratory technicians who were familiar with this occurrence indicated the blood center initially prepared and stored the cell product at their facility. The bag contained 51. 5ml of cell product. The bag was dry shipped inside its cassette for delivery to a hospital for patient infusion. The hospital removed the bag from the cassette and initiated the thawing process. During thawing, fluid from the bag was observed leaking from the bag. The leak was reported to be from a small cut in the middle of the bag. There was no label in the area where the cut was observed. The cell material contained in the bag was salvaged and infused into a patient. Any additional treatment which may have been required as a result of this report was not available. The hospital has reported no serious injury or death as a result of this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1066733-2018-00001 |
| MDR Report Key | 7288477 |
| Date Received | 2018-02-22 |
| Date of Report | 2018-02-22 |
| Date of Event | 2018-01-17 |
| Date Mfgr Received | 2018-01-22 |
| Device Manufacturer Date | 2016-11-11 |
| Date Added to Maude | 2018-02-22 |
| 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 | 2018-02-22 |
| Model Number | CF-250 |
| Catalog Number | CF-250 |
| Lot Number | 147402 |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-02-22 |