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

Model Number NOT APPLICABLE

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/26/2018

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 g129 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g129 for the reported issue shows no trends.Trends were reviewed for complaint category, tubing leak.No trends were detected for this complaint category.A photograph and video were provided by the customer for evaluation.A review of the photograph shows the orange striped anticoagulant line and spike chamber.The photograph confirms a leak at the joint between the tubing and chamber.The root cause of the leak was most likely manufacturing operator error due to a weak bond joint during the tube bonding process.Re-training has been completed for manufacturing operators who perform this operation.No further action is required at this time.This investigation is now complete.(b)(4).

Event Description

The customer called to report a tubing leak during the treatment procedure.The customer stated approximately 1100 ml of whole blood was processed when they noticed a leak coming from the tubing connected to the anticoagulant spike chamber.The customer stated they noted clear fluid dripping from the tubing.The customer contacted the physician who instructed the operator to proceed to the buffy coat collection phase of the procedure.The customer stated the patient was stable.The customer has returned a photograph and video 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: 7941306
• MDR Text Key: 124131980
• Report Number: 2523595-2018-00157
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 10/06/2018

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: 04/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: G129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2018
• Initial Date FDA Received: 10/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2018
• 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