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

Model Number NOT APPLICABLE

Device Problems Break (1069); Unintended Ejection (1234); Fluid/Blood Leak (1250)

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

Event Date 07/30/2018

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 g120 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g120 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.The complaint kit, smartcard and photographs were returned for investigation.A review of the data recorded on the smartcard verified the treatment was completed and no blood leak alarms were recorded on the card.The photographs provided by the customer show a line of red spatter running across the inside of the centrifuge on the wall and on the inside of the centrifuge door.The returned kit was examined and found no evidence that a blood leak had occurred.The centrifuge bowl and drive tube component of the kit were pressurized and held under water, no bubbles emerged from either component.The centrifuge bowl and drive tube were installed onto a test instrument for dynamic testing.The centrifuge was spun at 2400 rpm for 12 minutes; the centrifuge leak sensor did not indicate any leaks.The centrifuge was checked after testing and found no residue or leaks on the centrifuge walls.Pressure testing and dynamic testing of the bowl and drive tube did not find any leaks.The root cause of the reported centrifuge bowl leak/break could not be determined as no cellex kit defect could be identified upon evaluation of the returned product.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 the treatment was completed successfully and the patient was disconnected.The customer stated they opened the centrifuge door to unload the kit and discovered blood spray around the centrifuge chamber walls and centrifuge door.The customer stated the patient was stable.The customer has returned the kit, smartcard 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: 7824205
• MDR Text Key: 118757182
• Report Number: 2523595-2018-00133
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: G120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2018
• 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: 75 YR
• Patient Weight: 67