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 05/14/2018

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 g306 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g306 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 kit 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 148 ml of whole blood was processed when the centrifuge 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 the kit for investigation.

Manufacturer Narrative

The kit and smartcard were returned for investigation.A review of the data recorded on the returned smartcard found an alarm #7: blood leak (centrifuge chamber) alarm was received after 148 ml of whole blood had been processed.Examination of the received kit verified the centrifuge bowl leak/break as it was broken into pieces.The outer centrifuge bowl fragments were inspected and found parent material along the entire weld edge between the base and outer bowl.The inspection found no evidence of a weld failure as the weld remained intact when the centrifuge bowl impacted the centrifuge chamber wall.A material trace of the bowl assemblies and components used to manufacture kit lot g306 found no related nonconformances.A retain kit for lot number g306 was measured for weld engagement and found to be within specification requirements.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 centrifuge bowl was not effectively secured into the instrument bowl holder, allowing the bowl to disconnect from the holder and impact the centrifuge chamber wall.However, the root cause for why the centrifuge bowl was not properly secured into the holder 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.07/27/2018.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 7592648
• MDR Text Key: 111327322
• Report Number: 2523595-2018-00099
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G306(17)200101
• 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: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 01/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 74