MAUDE Adverse Event Report: CHARTER MEDICAL, LTD. 55 - 100 ML CRYOGENIC STORAGE CONTAINER

Model Number CF-500

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2019

Event Type  malfunction  

Manufacturer Narrative

A single, used device was received for investigation.The returned bag was visually inspected; no issues were observed.The bag was inflated with compressed air and leak tested under water; a leak was detected in the film at the base of the center filler tube port.The leak was verified to be from a hole in the film, approximately 1/32-inch long.No other issues were observed on the returned bag.The user indicated their investigation determined the bag was damaged during handling after it was removed from cryogenic storage and being prepared for thawing.The ifu for this product states "port tubes and film are fragile in the frozen state and breakage may occur.Handle with care.".

Event Description

The customer reported a bag breakage for a single cf-500 device.The customer indicated their internal investigation determined the bag was damaged during handling at their facility after it was removed from cryogenic storage and being prepared for thawing.The contents of the bag were administered to a patient.The user facility has a broken bag protocol, which requires collection of blood test cultures from the recipient along with prophylactic antibiotics.The blood culture tests were negative.There were no reports of patient injury or death as a result of this occurrence.

• Brand Name: 55 - 100 ML CRYOGENIC STORAGE CONTAINER
• Type of Device: 55 - 100 ML 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: todd meinecke ; 3948-a westpoint blvd.; winston salem, NC 27103 ; 3367686447
• MDR Report Key: 8628777
• MDR Text Key: 145942138
• Report Number: 1066733-2019-00003
• Device Sequence Number: 1
• Product Code: LPZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK1000049
• 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: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2022
• Device Model Number: CF-500
• Device Catalogue Number: CF-500
• Device Lot Number: 153723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2018
• 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