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

Model Number NOT APPLICABLE

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

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 07/02/2018

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 g318 was conducted.There were no non-conformance's associated with this lot.This lot met all release requirements.A review of kit lot g318 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 and 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 200 to 500 ml of whole blood was processed.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 and photographs for investigation.

Manufacturer Narrative

The complaint kit, smartcard and photographs 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 210 ml of whole blood was processed.The customer provided photographs show the centrifuge chamber and verify the centrifuge bowl broke during the treatment.The outer component of the centrifuge bowl is mostly intact and the base of the bowl is still attached to the bowl holder.Examination of the returned kit found all four bowl locating tabs were undamaged and attached to the bowl cover.Further inspection of the returned centrifuge bowl showed a horizontal crack indicating the break occurred in the parent material of the bowl and not a separation at the weld that joins the components.A material trace of the bowl assembly and its components used to build lot g318 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 root cause of the centrifuge bowl break was due to a material failure in the parent material of the outer bowl.However, the cause of the material failure could not be determined based on the available information.No manufacturing related defects were identified through this investigation.No further action is required at this time.This investigation is now complete.(b)(4).(b)(6) 2018.

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 g318 was conducted.There were no non-conformance's associated with this lot.This lot met all release requirements.A review of kit lot g318 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 and 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 200 to 500 ml of whole blood was processed.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 and photographs for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• Manufacturer (Section G): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; college business & tech park; cruiserath road; blanchardstown, dublin D15 T X2V; EI D15 TX2V
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 7736678
• MDR Text Key: 115683366
• Report Number: 2523595-2018-00117
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G318(17)200201
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 0