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

Model Number CLXECP

Device Problems Defective Alarm (1014); Fluid/Blood Leak (1250)

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

Event Date 10/05/2017

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 f127 was conducted.There were no non-conformances.This lot met all release requirements.A review of kit lot f127 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 photograph is still in progress.A supplemental report will be filed when the analysis is complete.

Event Description

Customer called to report a tubing leak during the treatment procedure.The customer stated the tubing detached from the hematocrit cuvette during the first phase of buffy coat collection and leaked onto the pump deck.No alarms were reported to have occurred during the treatment.The treatment was aborted.The blood from the centrifuge bowl and contents of the return bag were manually returned to the patient.The customer stated the patient was stable and not impacted by the incident.The patient was successfully treated on another instrument following this event.The customer has returned photographs for investigation.

Manufacturer Narrative

A photo analysis was conducted for this complaint.A review of the customer provided photographs confirm there was a blood leak during treatment.The customer provided photographs shows the tube to the hematocrit sensor is detached.The cause of the tubing becoming detached could not be determined based on the photographs.A material trace of the hematocrit cuvette assembly and its components used to build lot f127 did not find any nonconformances.The device history record review did not result in any related non-conformances and this kit lot had passed all lot release testing.The root cause of the leak could not be determined based on the information provided.This investigation is now complete.(b)(4).

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• 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: 6988883
• MDR Text Key: 91935294
• Report Number: 2523595-2017-00197
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

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: 07/01/2019
• Device Model Number: CLXECP
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: F127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/05/2017
• Initial Date FDA Received: 10/30/2017
• Supplement Dates Manufacturer Received: 12/07/2017
• Supplement Dates FDA Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2017
• 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