MAUDE Adverse Event Report: THERAKOS INC. CELLEX PHOTOPHERESIS SYSTEM

Model Number CLXUSA

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

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

Event Date 11/06/2019

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 h323 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h323 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 photographs and kit is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

The customer contacted mallinckrodt to report that they experienced a centrifuge bowl leak/break with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer stated that approximately 233 mls of whole blood was processed at the time the leak occurred and that there were no alarms.Customer stated that the treatment was aborted and the patient was stable.The customer returned photographs and the kit for investigation.

Manufacturer Narrative

The customer returned photographs, several kit components, and the smart card for investigation.A review of the smart card data determined that the centrifuge bowl leak/break likely occurred after 233 ml of whole blood had been processed as an alarm #7: blood leak? (centrifuge chamber) alarm had occurred.A review of the customer photographs identified that the centrifuge bowl base is still retained within the cellex instrument's centrifuge bowl holder indicating that the centrifuge bowl did not dislodge from the cellex instrument's centrifuge bowl holder during treatment.Visual inspection of the returned kit components confirms the broken centrifuge bowl with the outer bowl base still intact.All four locating tabs of the centrifuge bowl base were present, flat, and undamaged.No manufacturing issues were identified with the kit that may have caused or contributed to the reported failure.A material trace of the centrifuge bowl assembly and its components used to build lot h323 found no related non-conformances.The requested device history record review did not result in any related non-conformances.This lot passed all lot release testing.The centrifuge bowl leak/break likely occurred due to a breakage in the centrifuge bowl material and not the weld between the outer centrifuge bowl and centrifuge bowl base.However, a root cause for the breakage in the centrifuge bowl material could not be determined based on the available information.No further action required at this time.Mc: 047104 s.D.A.(b)(6)2020.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS INC.; bedminster NJ 07921
• MDR Report Key: 9422602
• MDR Text Key: 198759699
• Report Number: 2523595-2019-00145
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)H323(17)210401
• 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: 01/16/2020

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: 04/01/2021
• Device Model Number: CLXUSA
• Device Catalogue Number: CLXUSA
• Device Lot Number: H323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 12/20/2019
• Supplement Dates FDA Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 119