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

Model Number CF-250

Device Problems Break (1069); Fracture (1260); Device Issue (2379); Material Integrity Problem (2978)

Patient Problem No Code Available (3191)

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

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.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.

Event Description

The end user experienced a leak from a possible film tear in a cf-250 device while the bag was being thawed.The cell product was infused into the 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: 7542103
• MDR Text Key: 109518072
• Report Number: 1066733-2018-00010
• 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: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/02/2021
• Device Model Number: CF-250
• Device Catalogue Number: CF-250
• Device Lot Number: 151496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 YR