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 12/12/2019

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 h243 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h243 shows no trends.Trends were reviewed for complaint categories, drive tube leak/break and alarm #7: blood leak? (centrifuge chamber).No trends were detected for each complaint category.This assessment is based on the information available at the time of the investigation.At the time of this report, the analysis of the returned kit and smart card is still in progress.A supplemental report will be filed when the analysis is 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 before the buffy coat collection phase of the procedure they received an alarm #7: blood leak (centrifuge chamber) alarm.The customer inspected the centrifuge chamber and noticed the drive tube was damaged at the location of the lower drive tube bearing retainer clip.The customer aborted the ecp treatment and did not return residual blood within the kit to the patient.The customer reported the patient was in stable condition and not impacted by the incident.The customer has returned the kit and smart card for investigation.

Manufacturer Narrative

The complaint kit and smart card were returned for evaluation.A review of the data recorded on the smart card shows that prime was completed without incident and blood collection began in single needle mode.The treatment proceeded until an alarm #7: blood leak? (centrifuge chamber) alarm occurred after 1425 ml of whole blood was processed.Examination of the received kit found the drive tube in one piece.The lower bearing stop on the drive tube is worn down and the lower drive tube bearing was below the bearing stop.The drive tube was pressure tested to check for leaks and a leak was verified at the location just below the lower bearing stop.A material trace of the drive tubes used to build lot h243 did not find any non-conformances.A device history record review did not identify any related nonconformances and this kit lot had passed all lot release testing.The cause of the drive tube leak is due to a groove cut into the drive tube by the drive tube bearing.The root cause of what caused the bearing to damage the drive tube could not be determined based on the available information.No further action is required at this time.This investigation is now complete.Mc: (b)(4).P.T.27-feb-2020.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 9578644
• MDR Text Key: 196079465
• Report Number: 2523595-2020-00004
• 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: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: H243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Date Manufacturer Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 12 YR