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 Consequences Or Impact To Patient (2199)

Event Date 01/17/2018

Event Type  malfunction  

Manufacturer Narrative

The complaint sample, or pictures of the complaint device, was not returned to the manufacturer for investigation/review.The reported leak did not occur during filling of the bag, which suggests the leak likely occurred during handling after the bag was frozen.The cassette containing the bag was handled at the blood center during shipping preparation, and the cassette and bag was handled at the hospital.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.The precautions indicated above are addressed in the product ifu's.

Event Description

A blood center customer reported they were made aware on (b)(6) 2018, from a hospital client, that one of their cell freeze ln2 freezing containers was broken.Phone conversations with laboratory technicians who were familiar with this occurrence indicated the blood center initially prepared and stored the cell product at their facility.The bag contained 51.5ml of cell product.The bag was dry shipped inside its cassette for delivery to a hospital for patient infusion.The hospital removed the bag from the cassette and initiated the thawing process.During thawing, fluid from the bag was observed leaking from the bag.The leak was reported to be from a small cut in the middle of the bag.There was no label in the area where the cut was observed.The cell material contained in the bag was salvaged and infused into a patient.Any additional treatment which may have been required as a result of this report was not available.The hospital has reported no serious injury or death as a result of this occurrence.

• 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: 7288477
• MDR Text Key: 100913040
• Report Number: 1066733-2018-00001
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 11/10/2020
• Device Model Number: CF-250
• Device Catalogue Number: CF-250
• Device Lot Number: 147402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/11/2016
• 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