MAUDE Adverse Event Report: THERAKOS INC. CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Break (1069); Leak/Splash (1354); Detachment of Device or Device Component (2907)

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

Event Date 11/28/2018

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 g355 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g355 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.A review of the customer provided photographs confirm the drive tube break occurred during treatment as blood splatter is seen in the centrifuge chamber.The photographs show what appears to be the upper drive tube bearing at the bottom of the centrifuge chamber, and the lower bearing still in the retainer clip.The drive tube is broken in half, near the upper drive tube bearing stop.The photographs show the centrifuge bowl is intact and still secured into the bowl holder.A device history record review did not identify any related nonconformances and this kit lot had passed all lot release testing.The root cause of the reported drive tube leak/break could not be determined based on the available information.No further action is required at this time.This investigation is now complete.Investigation complete.Mc: (b)(4).(b)(6) 12/21/2018.

Event Description

The customer called to report a drive tube leak/break during the treatment procedure.The customer stated approximately 151 ml of whole blood was processed at the time the break occurred.The customer stated the drive tube had detached from the top of the centrifuge bowl, and the centrifuge bowl was still secured in the bowl holder.The customer stated the patient was stable and started treatment on another 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: 8188992
• MDR Text Key: 131325861
• Report Number: 2523595-2018-00175
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G355(17)200801
• 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: 12/21/2018

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: 08/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2018
• 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: 73 YR
• Patient Weight: 86