MAUDE Adverse Event Report: CHARTER MEDICAL, LTD. 75-ML CELL FREEZE CRYOGENIC STORAGE CONTAINER

Model Number CML-75LN

Device Problems Break (1069); Crack (1135); Fracture (1260); Device Issue (2379); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2017

Event Type  malfunction  

Manufacturer Narrative

The sample was not available for investigation, however an image of a portion of the bag was provided.The image included a portion of a customer applied label on the bag.A conversation with the complaint reporter confirmed a user-applied label was adhered to the film surface of the bag.The image provided minimal details of a top quadrant of the bag, including a portion of 2 ports.A crack in the film appeared to be located below one of the ports.One end of the crack was covered with the customer applied label and the full length of the crack was unknown.An estimate of the visible crack length was approximately 0.5-inch.A film crack the size of the one observed on the returned sample would have resulted in a detectable leak during filling of the bag.Therefore, it can be concluded that the crack likely occurred during freezing or thawing.The root cause of the film crack could not be conclusively determined.There is a possibility that a label attached to the bag surface could interfere with the flexibility of the film during cryogenic freezing and thawing processes.However, 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 146908 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." sample not returned to charter medical.

Event Description

The bag break was discovered during the thawing process.There was no contact with a patient when the leak occurred.There was no injury, death or further medical intervention required as a result of this occurrence.There was no medical staff exposure as a result of this occurrence.

• Brand Name: 75-ML CELL FREEZE CRYOGENIC STORAGE CONTAINER
• Type of Device: 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: 6566292
• MDR Text Key: 75325296
• Report Number: 1066733-2017-00004
• Device Sequence Number: 1
• Product Code: LPZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK060042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Expiration Date: 08/01/2019
• Device Model Number: CML-75LN
• Device Catalogue Number: CML-75LN
• Device Lot Number: 146908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/24/2016
• 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