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 Known Impact Or Consequence To Patient (2692)

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

The bag was not returned for investigation.The user provided a picture of a bag, which indicated a film fracture below the bottom of one of the port tubes.A film crack the size of the one observed in the picture would have likely resulted in a detectable leak during filling of the bag.Therefore, it can be concluded that the crack likely occurred during handling, freezing, or thawing.The root cause of the film crack could not be conclusively determined.The film crack under the 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 150211 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 user facility uses the 50-90 ml capacity cryobag cat #cml-75ln in their cell therapy program.They experienced a bag break involving a cml-75ln product from lot number #150211.When thawed, a leak was observed from a seam between the port and the body of the bag.The cells were salvaged and infused into a patient.There was no information available from the user regarding potential prophylactic treatments or any adverse event regarding 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: 7298035
• MDR Text Key: 101245728
• Report Number: 1066733-2018-00003
• 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: Other
• Type of Report: Initial
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 07/01/2020
• Device Model Number: CML-75LN
• Device Catalogue Number: CML-75LN
• Device Lot Number: 150211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/03/2017
• 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