MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-26 for 75-ML CELL FREEZE CRYOGENIC STORAGE CONTAINER CML-75LN manufactured by Charter Medical, Ltd..
[101245728]
The bag was not returned for investigation. The user provided a picture of a bag, which indicated a film fracture below the bottom of one of the port tubes. A film crack the size of the one observed in the picture would have likely resulted in a detectable leak during filling of the bag. Therefore, it can be concluded that the crack likely occurred during handling, freezing, or thawing. The root cause of the film crack could not be conclusively determined. The film crack under the port tube suggests the bag may have encountered physical stress at some point, potentially while being handled when the bag was in the frozen state, although the exact point in the process where the film crack occurred is unknown. There are other causes that could potentially result in a film crack or tear: overfilling the bag. An overfilled bag could create resistance during insertion and removal of the bag from the metal cassette. Excessive air left inside the bag after filling, resulting in rapid expansion during thawing. Moisture on the exterior surface of the bag or cassette interior when the bag is inserted into the metal cassette. Moisture may cause the bag film to freeze to the interior cassette surface, thus potentially resulting in damage when the frozen bag is removed from the cassette. An unknown material anomaly. The product instruction for use sheet is provided with each cml-75ln device. Review of the ifu version provided with lot 150211 has the following precautions: "after freezing, do not handle excessively. Port tubes and film are fragile in the frozen state and breakage may occur. Handle with care. " "do not overfill. " "remove as much air as possible from the container. " "ensure bag exterior and protective freezing cassettes are dry prior to initiating freezing protocol. Moisture on the exterior of the bag or on the cassette could cause adherence of the bag to the cassette resulting in difficulty of bag removal. "
Patient Sequence No: 1, Text Type: N, H10
[101245729]
The user facility uses the 50-90 ml capacity cryobag cat #cml-75ln in their cell therapy program. They experienced a bag break involving a cml-75ln product from lot number #150211. When thawed, a leak was observed from a seam between the port and the body of the bag. The cells were salvaged and infused into a patient. There was no information available from the user regarding potential prophylactic treatments or any adverse event regarding this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1066733-2018-00003 |
| MDR Report Key | 7298035 |
| Date Received | 2018-02-26 |
| Date of Report | 2018-02-26 |
| Date of Event | 2018-02-08 |
| Date Mfgr Received | 2018-01-26 |
| Device Manufacturer Date | 2017-08-03 |
| Date Added to Maude | 2018-02-26 |
| 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 | 75-ML CELL FREEZE CRYOGENIC STORAGE CONTAINER |
| Generic Name | CELL FREEZE CRYOGENIC STORAGE CONTAINER |
| Product Code | LPZ |
| Date Received | 2018-02-26 |
| Model Number | CML-75LN |
| Catalog Number | CML-75LN |
| Lot Number | 150211 |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 2018-02-26 |