MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT AVAIL

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2017

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.A batch record review of kit lot e356 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot e356 for the reported issue shows no trends.Trends were reviewed for complaint category, pressure dome membrane leak.No trends were detected for this complaint category.The assessment is based on the 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).Device not returned.

Event Description

The syster has been used for treatment.The customer had called up to report a system pressure dome leak at the start of procedure.Customer stated they were getting multiple collect pressure and return pressure alarms due to access issues.It was stated that one line was not working so well, so they tried to swap the lines and lowered the collect rate to 15 ml/min but alarms continued to occur.That is then when the system pressure dome leak was noted.Customer aborted the procedure, did not return blood/products to patient.Customer stated no one was splashed with fluids or injured.Customer stated that the patient is stable.They have placed tpa in the line and will start another procedure soon.Customer stated no alarms had occured during prime.Customer will not be returning product for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; 53 frontage drive po box 9001; hampton NJ 08827
• Manufacturer (Section G): THERAKOS, INC; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 53 frontage drive po box 9001; hampton, NJ 08827
• MDR Report Key: 6522585
• MDR Text Key: 73906186
• Report Number: 2523595-2017-00070
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)E356(17)181001
• 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
• Report Date: 04/26/2017

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: 10/01/2018
• Device Model Number: NOT AVAIL
• Device Catalogue Number: CLXUSA
• Device Lot Number: E356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2017
• Initial Date FDA Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2016
• 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 Weight: 68