MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Date 11/08/2017

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 f348 was conducted.There were no non-conformances.This lot met all release requirements.A review of f348 for the reported issue shows no trends.Trends were reviewed for complaint category, tubing 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 customer provided photos is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

The customer called to report a pump tubing organizer leak that occurred during treatment.The customer mentioned that the system had collected the first round of buffy coat and during the rinsing of the bowl is when the blood leakage had occurred.The customer stated that the blood had leaked on the pump deck and then inside of the recirculation pump.After further inspection it was noticed that the recirculation pump tubing had disconnected form the pump tubing organizer.The treatment was aborted with no blood returned to the patient.The customer stated that the patient was in stable condition and not affected by the incident.The customer has provided photographs from the incident to be investigated.

Manufacturer Narrative

The customer received kit confirms the reported tubing leak.The smartcard was evaluated and it shows that the prime was completed successfully.However, at the time of the tubing leak the smartcard showed several alarms had occurred.The investigation of the kit and customer provided photographs show that the recirculation pump tubing segment was not inserted inside of the t-connector that attaches to the plasma outlet line and the treatment bag inlet line.Based on the fact that the kit prime had been successfully completed and 1465 ml whole blood was processed, this confirms that the tube was attached at the start of treatment.The mark on the detached tubing indicates that the tube was inserted into the t-connector with solvent to form a bond.The suspect tube and bond socket were measured and found to meet the specification requirements dimensionally.No leaks were found during release testing of kit lot f348.A material trace of the components used to build lot f348 found no related non-conformances.The root cause of the reported tubing leak is most likely a weak/poor bonding joint that occurred during manufacture of the kit.A review of the complaint trending determined there have been no other reports of tubing leaks for kit lot f348.No further action required at this time.Investigation complete.Investigation complete.(b)(4).

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• Manufacturer (Section G): THERAKOS, INC; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 7099300
• MDR Text Key: 95767796
• Report Number: 2523595-2017-00217
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)F348(17)190801
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/15/2018

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: Nurse
• Device Expiration Date: 08/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: F348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2017
• Initial Date FDA Received: 12/08/2017
• Supplement Dates Manufacturer Received: 01/09/2018
• Supplement Dates FDA Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2017
• 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