MAUDE Adverse Event Report: THERAKOS INC. CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Leak/Splash (1354); Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction tubing leak.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 j334 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot j334 shows no trends.Trends were reviewed for complaint categories, tubing leak and alarm #1: air detected.No trends were detected for these complaint categories.This assessment is based on the information available at the time of the investigation.At the time of this report, the analysis of the kit is still in progress.A supplemental report will be filed when the analysis is complete.Comp (b)(4).S.D.A.(b)(6) 2020.

Event Description

The customer contacted mallinckrodt to report that they experienced a tubing leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported that they received an alarm #1: air detected warning during the purging air phase of the treatment.While addressing the alarm they noticed a tubing leak.The customer aborted the ecp treatment and did not return residual blood within the kit to the patient.The customer indicated the patient was stable and was treated on another cellex instrument.The customer returned the kit for investigation.

Manufacturer Narrative

The customer returned the kit with smart card for investigation.A review of the smart card data confirmed that an alarm #1: air detected warning for air in the collect line occurred after 21 mls of whole blood had been processed.The data showed the operator aborted the treatment after 55 mls of whole blood had been processed.The returned kit was pressure tested to check for leaks and a leak was verified at the bond between the red stripe tubing and the collect luer.The tubing is bonded to the luer during manufacturing.A material trace of the components used to build lot j334 found one related non-conformance.The related non-conformance was associated with male lure locks produced from cavity 4 measuring out of tolerance.All material related to the non-conformance was scraped.A review of mallinckrodt's complaint database found no similar reported issues for kit lot j334.A device history record review did not identify any related non-conformances and this kit lot had passed all lot release testing.The cause of the tubing leak was most likely a weak solvent bond between the tubing and the male luer lock.The root cause of the weak solvent bond was most likely a manufacturing operator error during the tube bonding process.Retraining has been completed for all bonding operators.No further action is required at this time.This investigation is now complete.(b)(4).S.D.A.(b)(6) 2021.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS INC.; bedminster NJ 07921
• MDR Report Key: 11010378
• MDR Text Key: 222039495
• Report Number: 2523595-2020-00129
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)J334(17)220501
• Combination Product (y/n): Y
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

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: 05/01/2022
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: J334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 12/23/2020
• Supplement Dates FDA Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1