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

Model Number NOT APPLICABLE

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2018

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 g327 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g327 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 the bowl broke during the purging air phase of the treatment.The customer stated after the break the bottom piece of the bowl was still attached in the bowl holder.The customer aborted the treatment and did not return blood to the patient.The customer stated the patient was stable.The customer discarded the kit and has returned photographs for investigation.

Manufacturer Narrative

A photographic analysis was conducted for this complaint.A review of the customer provided photographs verify a centrifuge bowl leak/break occurred during the treatment.The provided photographs show the base of the centrifuge bowl is intact and secured to the bowl holder.The outer bowl component has separated from the base, and broke into pieces within the centrifuge chamber.The photographs show the inner bowl components have also broken into several pieces.A material trace of the bowl assembly and its components used to build lot g327 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: 7802630
• MDR Text Key: 118094821
• Report Number: 2523595-2018-00127
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G327(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

• 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: G327
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/23/2018
• Initial Date FDA Received: 08/21/2018
• Supplement Dates Manufacturer Received: 08/29/2018
• Supplement Dates FDA Received: 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 40