MAUDE Adverse Event Report: THERAKOS INC. CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem Insufficient Information (4580)

Event Date 07/20/2020

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 j101 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot j101 shows no trends.Trends were reviewed for complaint category, tubing leak.No trends were detected for this complaint category.The customer returned a photograph for evaluation.A review of the photograph verifies the tubing leak and shows the male luer lock has disconnected from the collect line tubing.A material trace of the male luer lock used to build kit lot j101 did not find any non-conformances.A device history record review did not identify any related non-conformances and this kit lot had passed all lot release testing.The root cause of the tubing leak was most likely due to an insufficient bond by the manufacturing operator error during the tube bonding operation.Retraining has been completed with all bonding operators.No further action is required at this time.This investigation is now complete.(b)(4).

Event Description

The customer contacted mallinckrodt to report that they experienced a tubing leak with their cellex photopheresis kit ("kit") after an extracorporeal photopheresis (ecp) treatment.The customer reported the treatment was successfully completed and blood was returned to the patient.The customer reported the collect line tubing fell on the floor and the luer lock connection detached from the collect line tubing.The customer stated there were no leaks observed during the treatment.The customer returned a photograph 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: 10620957
• MDR Text Key: 221937593
• Report Number: 2523595-2020-00105
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 10/02/2020

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: 01/01/2022
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: J101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/03/2020
• Initial Date FDA Received: 10/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2020
• 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