MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591); Noise, Audible (3273)

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

Event Date 06/15/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction photoactivation module leak.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.Kit lot f318 was reviewed.There were no related non-conformances or deviations.This lot met all release requirements.A review of kit lot f318 shows no trends.Trends were reviewed for complaint categories, photoactivation module leak, alarm #8: blood leak (photoactivation chamber), and system error.No trends were detected for these complaint categories.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 and returned kit is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

Customer called to report a blood leak that had occurred in the photo chamber.The nurse had stepped away from the instrument while it was reinfusing the treated cells.Shortly after, the patient stated that she heard a loud pop.A system error 129 appeared on the screen followed by an alarm #8: blood leak in photo chamber.The customer had then inspected the photo plate and observed blood leaking from the bottom edge.The blood was said to be inside of the photo chamber.The customer stated that the light set is intact but does contain blood on the lamps.There were 105 hours left on the light set.There is also approximately 10 mls of blood inside of the photo chamber on the leak sensor strip.The patient was in stable condition and unaffected by the incident.The patient was released.The customer will provide photos and return the kit for investigation.

Manufacturer Narrative

The complaint kit and photographs were provided for analysis.Occurrence of the reported alarms (i.E., alarm #8: blood leak (photoactivation chamber) and system error) could not be verified as the kit's smartcard was not returned for evaluation.The customer provided photographs provide evidence of a cracked photoactivation plate, blood in the photoactivation chamber of the instrument and tat blood was present on the light set assembly.Review of the returned kit identified that a crack was present in the center of the photoactivation plate.As a result, the reported photoactivation module leak is verified.Kits undergo testing to identify leaks in the product prior to release.Furthermore, no leaking issues or alarms were reporting during priming of the kit; therefore, it is unlikely the cracked photoactivation plate was present during manufacturing, distribution or installation of the kit onto the instrument.The root cause of the crack was likely an abnormal pressure spike in the photoactivation plate assembly / circuit during treatment.An abnormal pressure spike in the photoactivation plate would explain the 'loud pop' reported by the customer and the introduction of blood onto the light set assembly.The cause of the pressure spike during the treatment could not be determine based on the available information.No manufacturing related defects were identified during the evaluation.Investigation complete.Correction- manufacturer contact address revised.Mc: (b)(4).A.B: (b)(6) 2017.

• 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: 6713670
• MDR Text Key: 80387489
• Report Number: 2523595-2017-00122
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)F318(17)190401
• 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: 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 04/11/2017
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: F318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2017
• 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
• Patient Age: 52 YR
• Patient Weight: 88