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 Foreign Body In Patient (2687)

Event Date 02/26/2018

Event Type  malfunction  

Manufacturer Narrative

The complaint sample was not returned to the manufacturer for investigation/review.However, a picture of the bag was forwarded by the user facility.The bag lot number, lot 150297, was visible from the picture.The picture indicated a bag with an open inlet tube and there was no visible evidence of a user applied seal on the inlet tube.The standard method of use for the cf-250 is for the user to fill the bag, apply a seal on the inlet tube, and discard the remaining un-needed tubing.The bag is then frozen.There are one of two potential scenarios: - the user's tube seal failed.- the tube broke below the user applied seal after the bag was frozen.The reported leak did not occur during filling of the bag or during the freezing process, which suggests the inlet tube break likely occurred after the bag was frozen.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 inlet tube to freeze/adhere to the cassette during the freezing process.A condition of this type could cause tube damage upon removal of a frozen bag from the cassette.- handling of the bag in the frozen state.The film and inlet tube of a frozen bag is fragile - inadvertent manipulation or impact on the bag could cause the inlet tube to fracture.Precautions to help prevent issues indicated above are addressed in the product ifu's.

Event Description

On (b)(6) 2018, after the technician thawed the bag containing autologous cell product, a leak was detected from a broken bag filler tube.A user sealed segment of the tube was detached from the bag.The technician clamped the remaining portion of the filler tube to prevent additional leaking.The bag initially contained approximately 60ml of cell product.The technician was able to recover 49ml of cell product, which was infused into a patient.Total cd34/kg cells infused was 2.061 e6 instead of 2.16 e6 cells that should have been infused.

• 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: 7430635
• MDR Text Key: 105756702
• Report Number: 1066733-2018-00008
• 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: No Information
• Device Expiration Date: 08/01/2021
• Device Model Number: CF-250
• Device Catalogue Number: CF-250
• Device Lot Number: 150297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 YR