MAUDE Adverse Event Report: CHARTER MEDICAL, LTD. 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER

Model Number CF-250

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

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

Event Date 03/13/2018

Event Type  malfunction  

Manufacturer Narrative

The complaint sample was not returned to the manufacturer for investigation/review.However, two pictures of the bag were forwarded by the user facility.A crack in the film was observed from the picture.The crack appeared to be approximately 3/8-inch long and ran inside the top perimeter weld of the bag.The crack extended into the bag interior, which appears to be the source of the reported leak.A crack of the size observed in the picture would have been detected during 100% leak testing at charter medical.Additionally, a film crack of this nature would have likely occurred while the film was in a frozen state.The reported leak did not occur during filling of the bag, which suggests the leak likely occurred during handling after the bag was frozen.Cf-250 devices are 100% leak tested during the cml manufacturing process (validated leak test).Since the production leak test pressurizes the bag to 10 psi (constrained), a leak of the nature on the returned sample would have been detected with the manufacturing leak test if the leak existed at that time.There was no additional information to suggest an exact root cause for this report.There are several potential issues which could contribute to a failure mode of this nature.Residual moisture on the outside of the bag when it was placed inside the cassette.Residual moisture could cause the bag to freeze/adhere to the cassette during the freezing process.A condition of this type could cause film damage upon removal of a frozen bag from the cassette.Handling of the bag in the frozen state.The film of a frozen bag is fragile - inadvertent manipulation or impact on the bag could cause the film to fracture.Precautions to help prevent issues indicated above are addressed in the product ifu's.

Event Description

At the time of thawing the a blood and/or marrow transplant product; a breakage near the port was reported.The bag contained approximately 60 ml of cell material.The incident involved loss of some product and obviously a breach of sterility.There was a small crack visible on the bag.Tech called supervisor immediately.The contents of the bag were not infused into the patient.The bag was disposed of by the user facility.The exact date of the occurrence is not available.

• Brand Name: 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER
• Type of Device: 30-70ML 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: 7430641
• MDR Text Key: 105901663
• Report Number: 1066733-2018-00007
• Device Sequence Number: 1
• Product Code: LPZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 07/01/2021
• Device Model Number: CF-250
• Device Catalogue Number: CF-250
• Device Lot Number: 149938
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 YR