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

Model Number CML-75LN

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2018

Event Type  malfunction  

Manufacturer Narrative

A single, used sample was received for investigation.The bag was charged with compressed air and leak tested under water; a leak was discovered from the left top corner of the bag.The area where the observed leak originated was examined, using a magnification inspection lamp, a small hole was verified in the film.The examination also revealed film wrinkles in the port area of the bag, which could be indicative of film misalignment during the manufacturing process.During the manufacturing process, the bag is placed onto tooling for a welding process, which requires manual alignment.As a result of the film misalignment observed on the returned sample the manufacturing tooling likely placed stress on the film at the location where the hole was observed, and produced a weak area in the film.

Event Description

Event report from user: autologous cryopreserved hpc, apheresis product was issued from the laboratory on (b)(6) 2018 after passing a visual inspection.Unit was transported to the transplant unit for infusion.During thawing of the unit in a 37-degree waterbath, it was noted that a small amount of fluid (<1cc) had accumulated inside of the sterile overwrap bag.At this time it was unknown if the fluid had originated from the product due to a bag integrity issue, or had originated from some other source (ice on unit, leak in overwrap bag, etc.).The thawed product was then removed and inspected for integrity.No issues were seen, so the infusion proceeded.Once the bag was accessed and inverted, it was noticed that a few small drops of product were leaking from near the access port.The port was clamped, and the spike was transferred to the alternate port and infusion continued.Ones the unit was fully infused, the empty bag was sent to the processing lab for analysis.The empty bag was rinsed with sterile saline, an the residual product/saline solution was inoculated into a pediatric bd bactec blood culture bottle.After roughly 24 hours of incubation, the bottle was flagged as positive and a gram stain was performed.Gram positive cocci in clusters were noted on the gram stain, and transplant physician along with infectious disease were notified.Febrile neutropenic orders were initiated on patient which included administration of antibiotics.At this time the patient was notified of the culture report, as well as recommendations for care.Documentation for contaminated/potential contaminated cellular therapy product was initiated.The organism was subsequently identified as staphylococcus hominis.Per infectious disease physicians, patient continued on daptomycin, discontinued ceftazidime.Close monitoring of the patient continued.Description of contributing factors or root cause: no bag integrity issues were noted during the processing phases.It was therefore surmised that the bag integrity issue occurred during steps following processing.It is possible that a manufacturer defect resulted n a weak point in the product bag.This weak point could have been exacerbated by the cryopreservation process or the mechanical action of the manual thawing process, resulting in a small fracture in the bag.The identification of staphylococcus hominis was determined to be a likely skin contaminate and not pathogenic per medical director.Our facility presumes this was a false positive due to the fact that following the infusion of the unit, the bag was handled by multiple personnel and transported to the processing lab in a non-sterile biohazard container.Follow-up: following the incident, the appropriate individuals were notified per policy (processing facility director, processing facility medial director, and program quality manager) and an action plan was created.A preliminary investigation of the product bag was performed at our facility.The origin of the leak was identified to be along a seam located adjacent to the port of the bag.The bag is subsequently set to be returned to the manufacturer (charter medical limited) for a full investigation and report to follow.The patient was started on antibiotics following the incident and did not develop any signs or symptoms of infection.Peripheral blood cultures were collected on the patient following the incident and were found to be negative.Engraftment was achieved without incident and within expected time period.No adverse event or complications were identified as a direct result of the incident.

• Brand Name: 75-ML CELL FREEZE CRYOGENIC STORAGE CONTAINER
• Type of Device: 75-ML 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: todd meinecke ; 3948-a westpoint blvd.; winston salem, NC 27103
• MDR Report Key: 8269194
• MDR Text Key: 135518542
• Report Number: 1066733-2019-00001
• Device Sequence Number: 1
• Product Code: LPZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK0600042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2020
• Device Model Number: CML-75LN
• Device Catalogue Number: CML-75LN
• Device Lot Number: 148961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2017
• 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