MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Leak/Splash (1354); Device Displays Incorrect Message (2591); Pressure Problem (3012)

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

Event Date 07/03/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction of the pressure dome membrane leak.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.A batch record review of kit lot f205 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot f205 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories, alarm #16: collect pressure, alarm #17: return pressure, alarm #52: collect line air detected and pressure dome membrane leak.No trends were detected for each complaint category.The assessment is based on the information available at the time of investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Investigation complete.(b)(4).A.B: (b)(4) 2017.

Event Description

Customer has called in to report that after an alarm #52: collect line air detected was posted at 871ml wbpv, the collect pressure dome had popped up from the sensor and leaked.The customer had also stated that several alarm #16: collect pressure and alarm #17: return pressure had occurred during the treatment.There was said to be no alarms that occurred during the priming of the kit.The customer aborted the treatment without returning the remaining volume.Patient was said to be in stable condition.The customer will not be returning the product for investigation.

• 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: 6735513
• MDR Text Key: 81140291
• Report Number: 2523595-2017-00139
• 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: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 01/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: F205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/03/2017
• Initial Date FDA Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2017
• 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
• Patient Age: 64 YR
• Patient Weight: 89