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

Model Number NOT APPLICABLE

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 10/18/2018

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 g347 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g347 shows no trends.Trends were reviewed for complaint categories, alarm #7: blood leak (centrifuge chamber) and centrifuge bowl leak/break.No trends were detected for each 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 kit is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).P.T.(b)(6) 2018.

Event Description

The customer called to report a centrifuge bowl leak/break during the treatment procedure.The customer reported approximately 300 ml of whole blood was processed at the time the break occurred.The customer stated they received an alarm #7: blood leak (centrifuge chamber) alarm.The customer aborted the procedure and did not return blood to the patient.The customer stated the patient was stable.The customer has returned the kit for investigation.

Manufacturer Narrative

The complaint kit, smartcard and pressure transducer were returned for investigation.The centrifuge bowl was received in several pieces verifying the centrifuge bowl break.The drive tube component of the kit was broken just below the upper bearing stop and detached from the centrifuge bowl.Examination of the centrifuge bowl indicated that the outer bowl had separated from the base resulting in the centrifuge bowl break.A review of the data recorded on the returned smartcard verified an alarm #7: blood leak (centrifuge chamber) occurred after 214 ml whole blood had been processed.The returned cellex instrument system pressure sensor was cleaned and installed on a test instrument for examination.The instrument was powered up in local diagnostic mode to check the operation of the sensor.The specified tolerance for the returned pressure sensor was found to be within specification.Pressure was applied to the sensor and reduced to verify the sensor readings would show an increase and decrease in pressure and the sensor responded appropriately.The returned sensor's performance was verified with a manometer per the standard calibration procedure without issue.The root cause of the centrifuge bowl break was most likely a separation of the outer bowl and bowl base.The cause of the separation could not be determined based on the available information.No further action is required at this time.This investigation is now complete.Mc: (b)(4).P.T.01/09/2019.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 8075823
• MDR Text Key: 129168565
• Report Number: 2523595-2018-00164
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G347(17)200701
• 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: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Date Manufacturer Received: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR