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 06/20/2018

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 g217 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g217 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.Photographs were provided by the customer for evaluation.A review of the photographs show a large portion of the centrifuge bowl still attached to the drive tube.The drive tube is still installed on the cellex instrument, and properly held in place by the drive tube retainer clips.An additional photograph shows the inner centrifuge bowl has separated yet is still intact.The photographs show portions of the outer bowl still welded in place indicating there was no failure in the weld.A review of the photographs concluded that most likely the centrifuge bowl came out of the centrifuge bowl holder while it was spinning and impacted the centrifuge chamber wall causing the break.However, the root cause of the centrifuge bowl disconnecting from the holder cannot be confirmed based on a review of the provided photographs.A device history record review did not identify any related nonconformances and this kit lot had passed all lot release testing.A material trace of the centrifuge bowl used to build lot g217 did not find any non-conformances.The root cause of the reported centrifuge bowl leak/break could not be determined based on the available information.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 approximately 50 ml of whole blood was processed at the time the break occurred.The customer aborted the treatment and did not return blood to the patient.The customer stated the patient was stable.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: 7687339
• MDR Text Key: 114433277
• Report Number: 2523595-2018-00113
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2018

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: 03/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: G217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 07/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2018
• 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