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

Model Number NOT APPLICABLE

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

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

Event Date 10/04/2018

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction drive tube 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 g339 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g339 shows no trends.Trends were reviewed for complaint category, drive tube leak/break.No trends were detected for this complaint category.Photographs were provided by the customer for evaluation.The reported drive tube leak/break is verified as the drive tube is twisted and blood splatter is visible throughout the centrifuge chamber.The centrifuge bowl appears to be intact and has dislodged from the bowl holder.The source of the blood leak could not be identified in the provided photographs.A device history record review did not identify any related non-conformances, deviations or unscheduled maintenance.This kit lot had passed all lot release testing.The root cause of the drive tube break was most likely improper installation of centrifuge bowl.The centrifuge bowl would have remained locked in the centrifuge bowl holder upon discovery of the drive tube leak/break if the centrifuge bowl tabs were properly locked into the centrifuge bowl holder.No further action is required at this time.Investigation complete.Mc: (b)(4).(b)(6) 10/23/2018.

Event Description

Customer called to report a drive tube leak/break during the treatment procedure.The customer stated that it looks like the upper bearing slipped out of place and caused the drive tube to tangle and the bowl to come out of the holder.The customer aborted the procedure and did not return blood to the patient.The customer stated the patient was stable.The customer 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: 7994996
• MDR Text Key: 124985849
• Report Number: 2523595-2018-00160
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G339(17)200601
• 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
• Report Date: 10/23/2018

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: 06/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2018
• Initial Date FDA Received: 10/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2018
• 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
• Patient Age: 17 YR
• Patient Weight: 50