MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Device Alarm System (1012); Break (1069); Fluid/Blood Leak (1250); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/03/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction of the centrifuge bowl leak/break.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.A batch record review of kit lot f219 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot f219 for the reported complaint issue shows no trends.Trends were reviewed for complaint category, centrifuge bowl leak/break.No trends were detected for this complaint category.This assessment is based on information available at the time of the investigation.At the time of this report, the analysis of the returned photos is still in progress.A supplemental report will be filed when the analysis of the photos is complete.(b)(4).

Event Description

The customer emailed to report a centrifuge bowl leak/break.The customer stated that during the buffy coat phase of the treatment, they noticed a small amount of dark reddish "powder" under the centrifuge door.The customer reported that they proceeded with the treatment and when they lifted the centrifuge door, they saw more "powder" sprayed on the walls of the centrifuge.The customer stated that they believed that the "powder" was dried blood.The customer reported that they could not locate a leak within the centrifuge bowl.The customer stated that the instrument did not alarm at any point.The customer reported that the treatment was completed and all blood/products were returned to the patient, as they "considered the risk for contamination to be very minimal".The customer stated that the patient's condition was "normal" after the treatment.The customer reported that they do not want to return the kit.Photos were submitted for investigation.

Manufacturer Narrative

A photo analysis was conducted for this complaint.A review of the photos confirmed the leak, as the photos indicated that there was a leak within the centrifuge chamber.The leak appeared to have originated from the centrifuge bowl as there was blood on both the inside section of the drive tube locking arm and on the drive tube itself.The leak was aligned with the centrifuge bowl which also indicated that the leak came from the centrifuge bowl.A potential breach in the bowl could be a possible cause for this type of leak, however this could not be determined based on the available information.The root cause for the centrifuge bowl leak could not be determined as it was not clear based on the information provided where the leak originated from within the bowl.The device history record (dhr) review did not result in any related non-conformances and this kit lot had passed all lot release testing.A material trace of the centrifuge bowl components that were used to build this kit lot did not find any related non-conformances.All centrifuge bowl assemblies are leak tested during production and they are leak tested again before release as part of the finished kit.These leak tests are in place in order to detect any breach of the bowl assemblies before the kits are released.No further actions are required at this time.This investigation is now complete.(b)(4).

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC; bedminster NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 6838771
• MDR Text Key: 86100901
• Report Number: 2523595-2017-00164
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 04/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: F219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/03/2017
• Initial Date FDA Received: 09/01/2017
• Supplement Dates Manufacturer Received: 08/30/2017
• Supplement Dates FDA Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 84