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

Model Number CML-75LN

Device Problems Break (1069); Fracture (1260); Use of Device Problem (1670); Device Issue (2379); Material Integrity Problem (2978); Physical Property Issue (3008); Device Handling Problem (3265)

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

Event Date 05/04/2017

Event Type  malfunction  

Manufacturer Narrative

The cml-75ln is a cryogenic storage container consisting of a 75-ml bag with a fill tube and 2 spike ports.A pre-printed bag label is molded into the side of the bag during manufacturing.The label is intended to provide a means for recording contents information and remain permanently attached to the bag throughout the cell preservation and transfer/transfusion processes.A single used bag was received for investigation.Adhesive from what appeared to be a user applied label was present on the bag surface.The cml-75ln label, molded into the side of the bag, had been removed, presumably by the user.An irregular film tear, approximately 4-inches in length, was observed on the top portion of the bag.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.There are other causes that could potentially result in a 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.- although there was no evidence, there is always the possibility that an undetected material issue could contribute to a tear of this nature.The product instruction for use sheet is provided with each cml-75ln device.Review of the ifu version provided with lot 145438 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.".

Event Description

On (b)(6) 2017, a cml-75ln device containing frozen cell product was being prepared for transfusion to a patient.While the cml-75ln device was undergoing the thawing process, a loud crack (pop) was heard and a bag break was noticed.The product was not in contact with a patient during the thawing process.Prophylactic antibiotics were administered to the patient prior to the transfusion process.The transfusion facility salvaged the cell material from the cml-75ln device, and infused an unknown amount of the cell material into the patient.A precautionary antibiotic was administered to the patient.

• 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: 6612734
• MDR Text Key: 76836033
• Report Number: 1066733-2017-00005
• 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: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/01/2019
• Device Model Number: CML-75LN
• Device Catalogue Number: CML-75LN
• Device Lot Number: 145438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2016
• 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