MAUDE Adverse Event Report: CHARTER MEDICAL, LTD. 75-ML CELL FREEZE CRYOGENIC STORAGE CONTAINER

Model Number CML-75LN

Device Problems Break (1069); Fracture (1260); Stretched (1601); Device Issue (2379); Material Deformation (2976); Material Distortion (2977); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2017

Event Type  malfunction  

Manufacturer Narrative

The bag was retained by the user and sent to charter medical for investigation.The bag was visually inspected and 2 items of interest observed on the bag film located in the area below the left port tube.Film deformation (i.E.Stretched) in the area of base of the port tube, approximately 0.30-inch long.A film tear in the deformed area, which was approximately 0.03-inches in size.A film tear of the size observed on the returned sample would have likely resulted in a detectable leak during filling or thawing of the bag.The root cause of the film distortion or leak could not be conclusively determined.The film deformation under the right port tube suggests the bag may have encountered physical stress at some point, potentially while being handled when the bag was in the frozen state, although the exact point where the film deformation occurred is unknown.Since the film directly under the right port tube had indications of stress deformation, and the leak occurred after spiking, this would suggest the spiking process further exacerbated the film deformation and potentially resulted in the tear and leak.There are other causes that could potentially result in a film deformation and a tear: overfilling the bag.An overfilled bag could create resistance during insertion and removal of the bag from the metal cassette.Excessive air left inside the bag after filling, resulting in rapid expansion during thawing.Moisture on the exterior surface of the bag or cassette interior when the bag is inserted into the metal cassette.Moisture may cause the bag film to freeze to the interior cassette surface, thus potentially resulting in damage when the frozen bag is removed from the cassette.An unknown material anomaly.The product instruction for use sheet is provided with each cml-75ln device.Review of the ifu version provided with lot 145909 has the following precautions: "after freezing, do not handle excessively.Port tubes and film are fragile in the frozen state and breakage may occur.Handle with care." "do not overfill." "remove as much air as possible from the container." "ensure bag exterior and protective freezing cassettes are dry prior to initiating freezing protocol.Moisture on the exterior of the bag or on the cassette could cause adherence of the bag to the cassette resulting in difficulty of bag removal.".

Event Description

The rn spiked the unit and then noticed a small leak.Approximately 3 ml of product was lost.Cultures on the unit are negative to date.The patient is doing well.The sample is available for return.The leak was noticed after the bag was spiked and while the infusion to the patient was in progress.The leak was from a small hole below the spike port.There was no change in the medication regime for the patient.There was no death or serious injury as a result of this occurrence.There was no medical staff exposure as a result of this occurrence.

• Brand Name: 75-ML CELL FREEZE CRYOGENIC STORAGE CONTAINER
• Type of Device: 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: 6370472
• MDR Text Key: 69148323
• Report Number: 1066733-2017-00001
• Device Sequence Number: 1
• Product Code: LPZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK060042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 05/01/2019
• Device Model Number: CML-75LN
• Device Catalogue Number: CML-75LN
• Device Lot Number: 145909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR