MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Detachment Of Device Component (1104); Leak/Splash (1354); Device Displays Incorrect Message (2591)

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

Event Date 08/08/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction pressure dome membrane leak.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.Kit lot f112 was reviewed.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot f112 shows no trends.Trends were reviewed for complaint categories, alarm #52: collect line air detected, pressure dome membrane leak.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 is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

The customer called to report an alarm #52: collect line air detected had sounded off at 640 ml whole blood process in single needle mode.The customer did observe air in the collect line and after resetting the alarm to continue the treatment, the customer realized that the system pressure dome popped off the sensor causing there to be a leak.The customer aborted the procedure and did not return any of the volume back to the patient.The patient was said to be in stable condition and did not need to be provided with infusion or transfusion.The customer agreed to send photos back for investigation.

Manufacturer Narrative

Review of the customer's complaint description determined the system pressure dome became detached from the system pressure sensor after approximately 640 ml of whole blood had been proceeded indicating the system had been functioning appropriately until that point.The customer provided one photograph for evaluation.The provided photograph shows the kit's system pressure dome is detached from the instrument's system pressure sensor.In addition, the photograph shows a pool of blood surrounding the instrument's system pressure sensor.As a result, the reported pressure dome membrane leak is verified based on the evaluation of the customer provided photograph.A root cause for the pressure dome membrane leak could not be determined based on the information provided in the customer's complaint description and customer provided photograph.No further investigation is required at this time.Investigation complete.Mc: (b)(4) a.B: (b)(6) 2017.

• 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: 6844636
• MDR Text Key: 86148202
• Report Number: 2523595-2017-00165
• 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,Followup
• Report Date: 09/22/2017

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: 02/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: F112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/08/2017
• Initial Date FDA Received: 09/06/2017
• Supplement Dates Manufacturer Received: 09/11/2017
• Supplement Dates FDA Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2017
• 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: 38 YR
• Patient Weight: 82