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

Model Number NOT APPLICABLE

Device Problems Device Displays Incorrect Message (2591); Gas/Air Leak (2946)

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

Event Date 10/10/2019

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 h328 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h328 for the reported issue shows no trends.Trends were reviewed for complaint categories, tubing leak and alarm #1: air detected.No trends were detected for each 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 kit is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

The customer called to report that they experienced a tubing leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer stated an alarm #1: air detected occurred, and air was visible in the pump tubing organizer (pto) and patient return line after approximately 468 ml of whole blood had been processed.During troubleshooting, the customer noticed that the return pump tubing segment was leaking.The ecp procedure was aborted and no residual blood within the kit was returned to the patient.The patient was reported to be in stable condition.The customer has provided the kit for investigation.

Manufacturer Narrative

The cellex photopheresis kit ("kit"), and smart card were returned for investigation.A review of the data recorded on the smart card verified approximately 468 ml of whole blood was processed when an alarm #1: air detected alarm occurred and the treatment was aborted.Physical inspection of the return kit shows the tubing that forms the return pump tubing segment was no longer attached to the "t' inside the pto that joins the tubing to the red cell pump tubing segment, and tubing going to the saline line and return bag outlet line.The root cause for the tubing leak is likely due to a weak solvent bond that was formed during the tube bonding operation.Manufacturing operators that perform the tube bonding function were provided with re-training as a result of this complaint.No further action is required at this time.This investigation is now complete.(b)(4).12-dec-2019.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 9296367
• MDR Text Key: 198759471
• Report Number: 2523595-2019-00130
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)H328(17)210501
• Combination Product (y/n): N
• 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: 12/12/2019

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: 05/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: H328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Initial Date Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 11/08/2019
• Supplement Dates Manufacturer Received: 11/12/2019
• Supplement Dates FDA Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Weight: 12