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

Model Number NOT APPLICABLE

Device Problem Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 06/14/2018

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 f121 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot f121 for the reported issue shows no trends.Trends were reviewed for complaint categories, tubing leak and alarm #53: return line air detected.No trends were detected for each complaint category.Photographs were provided by the customer for evaluation.A review of the photographs show a blood leak on the instrument pump deck beneath the return line tubing.The leak is confirmed based on the photographs provided; however, the origin of the leak could not be determined.A device history record review did not identify any related nonconformances and this kit lot had passed all lot release testing.A material trace of the tubing used to manufacture lot f121 showed no nonconformances.All kits are leak tested prior to packaging.There are no tubing bond joints in the area the leak was observed in the photograph.The root cause of the reported tubing leak could not be determined based on the available information.No further action is required at this time.This investigation is now complete.(b)(4).

Event Description

The customer sent an email to report a tubing leak during the treatment procedure.The customer reported at approximately 230 ml of whole blood processed they received an alarm #53: return line air detected alarm.The customer then noted a leak coming from the tubing on the instrument pump deck.The customer aborted the procedure and did not return blood to the patient.The customer has returned photographs 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: 7686484
• MDR Text Key: 114430783
• Report Number: 2523595-2018-00111
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: F121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2017
• 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
• Patient Age: 72 YR
• Patient Weight: 70