MAUDE Adverse Event Report: CHARTER MEDICAL, LTD. 75-ML CELL FREEZE CRYOGENIC STORAGE CONTAINER; CELL FREEZE CRYOGENIC STRAGE 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 11/07/2016

Event Type  malfunction  

Manufacturer Narrative

The bag was retained by the user and sent to charter medical for investigation.The bag was visually inspected; no anomalies were visibly detected.The bag was leak tested by inflating with compressed air - the bag would not remain inflated due to film tear on the front of the bag.The anomaly was characterized as a tear since the film on the edges of the opening had a jagged appearance.The film tear was approximately 0.40-inch long, and was located in the approximate center of the bag.No other issues were observed on the bag.A film tear of the size observed on the returned sample would have likely resulted in a detectable leak, during filling, before the bag was frozen.The root cause of the tear could not be conclusively determined.Since the report of the tear occurred after freezing and during the thawing process, this would suggest the tear likely occurred during handling or transportation of the bag while it was in a frozen condition.The exact point in the handling process where damage may have occurred is unknown.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.The product instruction for use sheet is provided with each cml-75ln device.Review of the ifu version provided with lot 141256 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

A leak occurred in a cryogenic storage container containing autologous stem cells in a 10% dmso solution.The bag was the third unit out of three units intended for infusion into a patient.All 3 units were received at the hospital and thawed at bedside.Two units were successfully infused into the patient.Upon hanging the 3rd unit, nurses detected a leak from the bag.The decision was made at that time not to infuse the stem cells from this 3rd unit since sufficient cell material was available from the previous 2 units.No further medical intervention was needed or necessary as a result of this complaint.

• Brand Name: 75-ML CELL FREEZE CRYOGENIC STORAGE CONTAINER
• Type of Device: CELL FREEZE CRYOGENIC STRAGE 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: 6152910
• MDR Text Key: 62331713
• Report Number: 1066733-2016-00004
• 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: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 03/01/2018
• Device Model Number: CML-75LN
• Device Catalogue Number: CML-75LN
• Device Lot Number: 141256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2015
• 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