MAUDE Adverse Event Report: CHARTER MEDICAL, LTD. 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER

Model Number CF-250

Device Problems Device Issue (2379); Material Integrity Problem (2978); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/27/2018

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER
• Type of Device: 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER
• Manufacturer (Section D): CHARTER MEDICAL, LTD.; 3948-a westpoint blvd; winston salem NC 27103
• Manufacturer (Section G): CHARTER MEDICAL, LTD.; 3948-a westpoint blvd.; winston salem NC 27103
• Manufacturer Contact: jessica hughes ; 3948-a westpoint blvd.; winston salem, NC 27103 ; 3367686447
• MDR Report Key: 7467973
• MDR Text Key: 106981499
• Report Number: 1066733-2018-00009
• Device Sequence Number: 1
• Product Code: LPZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 12/02/2020
• Device Model Number: CF-250
• Device Catalogue Number: CF-250
• Device Lot Number: 151496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR