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

Model Number NOT APPLICABLE

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 09/09/2019

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 h120 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h120 for the reported issue shows no trends.Trends were reviewed for complaint category, drive tube leak/break.No trends were detected for this complaint category.The assessment is based on the information available at the time of investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Investigation complete.(b)(4).

Event Description

The customer contacted mallinckrodt to report they experienced a drive tube leak/break with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported approximately 1425 ml of whole blood was processed when the break occurred.The customer aborted the ecp treatment and did not return residual blood to the patient.The customer stated the patient was stable.The customer did not return the product for evaluation.

Manufacturer Narrative

The customer provided photographs for investigation.Examination of the provided photographs verify the drive tube broke at the base of the drive tube where it is installed into the drive tube clamp.The upper and lower drive tube bearings are not installed into their respective drive tube bearing retainer clip.The photographs show the lower drive tube bearing has broken apart and is at the bottom of the centrifuge chamber.A material trace of the drive tube used to manufacture lot h120 showed no non-conformances.A device history record review did not identify any related non-conformances, deviations or equipment maintenance events.This kit lot had passed all lot release testing.The root cause for the drive tube 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).P.T.(b)(6) 2020.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 9186188
• MDR Text Key: 219198729
• Report Number: 2523595-2019-00114
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/16/2020

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: 04/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: H120
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 10/14/2019
• Supplement Dates Manufacturer Received: 06/22/2020
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1