MAUDE Adverse Event Report: CHARTER MEDICAL, LTD. 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER/3 LEADS

Model Number CF-250-3L

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

Patient Problem No Patient Involvement (2645)

Event Date 09/05/2018

Event Type  malfunction  

Manufacturer Narrative

The complaint sample was not available; however, the customer provided a picture of the bag.The picture indicated a film breakage under one of the two spike port components at the top of the bag.The film breakage appeared to extend across the width of the spike port component base.Since the leak was reported during the thawing process, the presumption is made that the film breakage did not exist during filling or prior to freezing.There are 2 possible causes for a failure mode of this nature: manual equipment reset.A capa investigation identified a manual equipment reset process on the equipment used to produce the cf-250 bags.The equipment is manually reset between welding cycles.If not fully reset, intermittent film stress could occur at the port/film interface.Film stress at the port/film interface could weaken the film and potentially contribute to film breakage during cryogenic freezing or thawing conditions.User handling: user handling of the device by the port tubes while the bag is in a frozen state.There are several possible conditions which could contribute to handling damage: 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

The end user of the product reported an incomplete seal on the top right part of the bag, at the right side of the spike port component.The issue was detected during product processing (thawing) in a laboratory setting; there was no patient involvement.

• Brand Name: 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER/3 LEADS
• Type of Device: 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER/3 LEADS
• 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: todd meinecke ; 3948-a westpoint blvd.; winston salem, NC 27103 ; 3367686447
• MDR Report Key: 7936386
• MDR Text Key: 123380972
• Report Number: 1066733-2018-00017
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/01/2021
• Device Model Number: CF-250-3L
• Device Catalogue Number: CF-250-3L
• Device Lot Number: 149035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/04/2017
• 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