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

Model Number NOT APPLICABLE

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2019

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction pump tubing organizer (pto) 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 g147 was conducted.There were no non-conformance's associated with this lot.This lot met all release requirements.A review of kit lot g147 for the reported issue shows no trends.Trends were reviewed for complaint category, pto leak.No trends were detected for this 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 photograph is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4) 2019.

Event Description

The customer called to report a pump tubing organizer (pto) leak during the treatment procedure.The customer stated a blood leak was observed at the beginning of the procedure when approximately 150 to 200 ml of whole blood was processed.The customer reported the leak was coming from a tubing joint within the pto.The customer aborted the procedure and did not return blood to the patient.The customer stated the patient was stable.The customer returned a photograph for investigation.

Manufacturer Narrative

A photograph of the complaint kit was provided by the customer for evaluation.The photograph verifies the reported pump tubing organizer (pto) leak as blood and air bubbles are seen leaking between the y-connector and yellow striped tubing.The cause of the leak was most likely a weak solvent bond joint between the y-connector and yellow striped tubing.The root cause of the leak 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.Mc: (b)(4).P.T.(b)(6) 2019.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 8771712
• MDR Text Key: 150576153
• Report Number: 2523595-2019-00074
• 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: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: G147
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1