MAUDE Adverse Event Report: THERAKOS, INC. CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Break (1069); Unintended Ejection (1234)

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

Event Date 07/13/2018

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction 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 for kit lot g323 was conducted.There were no non-conformance's associated with this lot.This lot met all release requirements.A review of kit lot g323 for the reported 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 the information available at the time of the investigation.At the time of this report, the analysis of the returned photographs is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

The customer called to report a centrifuge bowl leak/break during the treatment procedure.The customer stated approximately 211 ml of whole blood was processed at the time the bowl break occurred.The customer aborted the procedure and did not return blood to the patient.The customer stated the patient was stable and started treatment after on another instrument.The customer has returned photographs for investigation.

Manufacturer Narrative

A photographic analysis was conducted for this complaint.A review of the customer provided photographs confirm a centrifuge bowl leak/break occurred during the treatment.The photographs show the base of the centrifuge bowl is intact and secured in the bowl holder.In addition, the inner lower bowl assembly still located on the bowl base and holder.The outer bowl component has separated from the bowl base and is mostly intact at the bottom of the centrifuge chamber.A material trace of the bowl assembly and its components used to build lot g323 found no related non-conformances.A device history record review did not identify any related non-conformances, and this kit lot had passed all lot release testing.The investigation determined the outer component of the centrifuge bowl most likely separated from the base resulting in the break.However, the root cause of the centrifuge bowl break could not be determined based on the provided photographs.No further action is required at this time.This investigation is now complete.Mc: (b)(4).P.T.09/06/2018.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 7786543
• MDR Text Key: 117443197
• Report Number: 2523595-2018-00132
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G323(17)200401
• Combination Product (y/n): N
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G323
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1