MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Air Leak (1008); Break (1069)

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

Event Date 01/10/2018

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 f249 was conducted.There were no non-conformances.This lot met all release requirements.A review of kit lot f249 for the reported issue shows no trends.Trends were reviewed for complaint categories, alarm #53: return line air detected, tubing leak.No trends were detected for each complaint category.The customer provided photographs and returned the corresponding complaint kit back for investigation.Review of the customer photographs verified the saline line tubing was torn / damaged and not the anticoagulant line tubing as reported by the customer.Evaluation of the returned kit also determined there was evidence of a tear in the saline line tubing.Further evaluation of the provided photographs and returned kit identified that blood was present in the complaint kit indicating the reported tubing leak occurred during the treatment.A tear in the saline line would allow air to enter the return line of the kit resulting in the reported alarm #53: return line air detected.No alarms or other issues were reported to have occurred during priming of the kit; therefore, the saline line tubing was intact during kit prime.There were no non-conformances identified upon review of the device history record.Assembled kits are pressure tested to identify leaks prior to product packaging.As a result, it is unlikely the reported tubing leak was due to a manufacturing related defect.The root cause for the reported tubing leak could not be determine based on the available information.No further action is required at this time.Investigation complete.(b)(4).

Event Description

The customer called to report an alarm #53: return line air detected that occurred during the beginning of the treatment.The customer observed air in the return line and indicated the anticoagulant tubing line was damaged.The treatment was aborted with no volume returned back to the patient.The patient was said to be in stable condition and not affected by the incident.The customer returned photographs and the kit to be investigated.

• 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: 7248997
• MDR Text Key: 100009385
• Report Number: 2523595-2018-00024
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 02/07/2018

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: CLXECP
• Device Lot Number: F249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2018
• Initial Date FDA Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 71