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 11/14/2018

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 g131 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g131 for the reported issue shows no trends.Trends were reviewed for complaint categories, centrifuge bowl leak/break, alarm #45: red blood cell pump alarm.No trends were detected for each complaint category.Photographs were returned for evaluation.The smartcard was not returned; therefore, the alarm #45: red blood cell pump alarm could not be verified.A review of the customer provided photographs confirm the centrifuge bowl break occurred during treatment as it is seen in pieces at the bottom of the centrifuge chamber.The outer bowl component can be seen shattered at the bottom of the centrifuge chamber.The drive tube component of the kit appears to be intact and has separated from the centrifuge bowl.A material trace of the bowl assembly and its components used to build lot g131 found no related nonconformances.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 fully dislodged from the bowl holder and broke upon impacting the centrifuge chamber.The cause of the bowl dislodgement 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).

Event Description

The customer called to report a centrifuge bowl leak/break during the treatment procedure.The customer stated they received an alarm #45: red blood cell pump alarm at approximately 490 ml whole blood processed.The customer stated the centrifuge bowl broke at approximately 521 ml whole blood processed.The customer aborted the procedure and did not return blood to the patient.The customer stated the patient was stable and started a new treatment on a different instrument.The customer has returned 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: 8139581
• MDR Text Key: 130632492
• Report Number: 2523595-2018-00172
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: G131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1