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 04/05/2017

Event Type  malfunction  

Manufacturer Narrative

The bag was retained by the user and sent to charter medical for investigation.The bag was visually inspected and a single crack was observed on the bag film located in the area below the left port tube.The film crack was located on the right side of the port and was approximately (0.5-inch long).A film crack the size of the one observed on the returned sample would have likely 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.The film crack under the left 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 145909 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.".

Event Description

The bag began leaking during water bath thawing process.Upon further inspection, the bag had developed a crack (~1 cm) near the seal where one of the ports meets the bag.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: 6549414
• MDR Text Key: 74756020
• Report Number: 1066733-2017-00003
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Medical Technologist
• Device Expiration Date: 05/01/2019
• Device Model Number: CML-75LN
• Device Catalogue Number: CML-75LN
• Device Lot Number: 145909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2017
• 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