MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-29 for 75-ML CELL FREEZE CRYOGENIC STORAGE CONTAINER CML-75LN manufactured by Charter Medical, Ltd..
[98986674]
The sample was not available for investigation. Based on user provided photos, the film crack occurred under the port tube. Both photos also indicated an adhesive label attached to the surface of the bag in each photo. The user label attached to the bag in each photo may have contributed to the broken film that occurred during the thawing process. An adhesive label may have interfered with the flexible characteristics of the film, possibly resulting in the crack/tear observed from the bag photos provided by the user. Movement of the bag port tubes, while the bag is in a frozen state, could also potentially result the crack/tear observed from the bag photos provided by the user. The root cause of the film crack on the bag could not be conclusively determined and the exact point in the process where the film crack occurred is unknown. There are other potential causes that could result in a film crack or tear: - film damage incurred during handling of a frozen bag. - 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. - although there was no evidence, there is always the possibility that an undetected material issue could contribute to a tear of this nature. The product instruction for use sheet is provided with each cml-75ln device. Review of the ifu version provided with lot 148607 has the following precautions: - "do not write on bag surface, back side of label or adhere labels to bag surface. " - "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
[98986675]
On (b)(6) 2017, a single cml-75ln device containing frozen cell product was being prepared for transfusion to a patient. The seal of the bag opened during thawing, allowing product to leak out of the bag. In an occurrence of the nature above, the transfusion facility determines if leaked cell material is salvageable, or if the unit is discarded. If the transfusion facility salvaged the cell material from the cml-75ln device and infused the salvaged cell material into a patient, a precautionary antibiotic is administered to the patient. It is unknown if cell material from this reported occurrence was discarded or salvaged and infused into a patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1066733-2017-00010 |
| MDR Report Key | 7226196 |
| Date Received | 2018-01-29 |
| Date of Report | 2018-01-29 |
| Date of Event | 2017-12-20 |
| Date Mfgr Received | 2017-12-29 |
| Device Manufacturer Date | 2017-03-08 |
| Date Added to Maude | 2018-01-29 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | 75-ML CELL FREEZE CRYOGENIC STORAGE CONTAINER |
| Product Code | LPZ |
| Date Received | 2018-01-29 |
| Model Number | CML-75LN |
| Catalog Number | CML-75LN |
| Lot Number | 148607 |
| 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 | 2018-01-29 |