MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Device Displays Incorrect Message (2591); Improper Flow or Infusion (2954)

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

Event Date 07/04/2017

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 f219 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot f219 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories, pressure dome membrane leak and alarm #16: collect pressure.No trends were detected for these complaint categories.The assessment is based on information available at the time of the 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.(b)(4).

Event Description

The customer called to report an alarm #16: collect pressure alarm and a pressure dome membrane leak.The customer stated that after several alarm 16: collect pressure alarms had occurred during the treatment, they decreased the collect rate to 15 ml/min.The customer reported that as the buffy coat began to form, the collect rate fell to 5 ml/min and the buffy coat would not move out of the bowl.The customer stated that they then paused the instrument and swapped the lines as the treatment was in double needle mode.The customer reported that the collect rate then increased and the buffy coat collection started again.The customer stated that after the first phase of buffy coat collection, they decided to manually end the buffy coat collection.The customer reported that immediately after ending the buffy coat collection, the system pressure dome's membrane "popped out" and a leak occurred.The customer stated that the treatment was aborted with no return of blood/products to the patient.The kit was not returned for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC; 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: 6762560
• MDR Text Key: 81960832
• Report Number: 2523595-2017-00137
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 08/02/2017

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: 04/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: F219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/04/2017
• Initial Date FDA Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2017
• 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: 29 YR
• Patient Weight: 83