MAUDE Adverse Event Report: THERAKOS, INC THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Lot Number E327-KIT

Device Problems Fluid/Blood Leak (1250); Pressure Problem (3012)

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

Event Date 08/24/2016

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot e327 was conducted.There were no nonconformances associated with this lot.The lot met release requirements.The (b)(4) lot number was not provided as it was not administered.However, a review of all (b)(4) lots manufactured since january 2013 was performed.No trends or nonconformances related to the complaint were noted.Trends were reviewed for complaint category, pressure dome membrane leak.No trends were detected for this complaint category.Service order report, #(b)(4), feedback: the service technician cleaned the instrument's pump deck and replaced the pressure sensor gasket.The system checkout procedure was then successfully performed.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).Device not returned to manufacturer.

Event Description

The customer reported that a leak occurred at the system pressure dome after 210 ml of whole blood processed.The customer stated that the treatment was paused when the leak occurred, due to the customer having to check the patient's iv access.The customer reported that the leak occurred suddenly and that the system pressure dome had just "popped up".The customer stated that no alarms occurred, and that prime had also been completed without any alarms.The customer reported that the treatment was aborted with no blood/products returned to the patient.The customer stated that the patient was in stable condition.Service was requested to clean the pump deck.The kit was not returned for investigation as it had already been discarded.

Manufacturer Narrative

The kit was received for analysis.The leak from the system pressure dome was confirmed upon visual inspection of the kit.The visual evaluation of the system pressure dome's diaphragm found that the diaphragm was partially unseated from the pressure dome.The inspection also found that there was dried blood on the body of the pressure dome, indicating that the leak occurred when the diaphragm became unseated.The diaphragm was pressed back onto the assembly body of the pressure dome and the reassembled pressure dome was installed onto a pressure sensor.The reassembled system pressure dome could be installed onto the sensor without any issues and the latches of the pressure dome fit into the circumferential groove around the sensor.A pressure test was performed in order to check for leaks while the pressure dome was still installed on the sensor.No leaks were detected.Thus testing did not indicate that there was an issue with the system pressure dome that may have caused or contributed to the leak.The cause for the system pressure dome leak could not determined, as no manufacturing related defects were confirmed during testing.Based on the analysis, no remedial actions will be conducted.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC; hampton NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; po box 9001; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 5965581
• MDR Text Key: 55670122
• Report Number: 2523595-2016-00219
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 08/24/2016

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: 05/01/2018
• Device Lot Number: E327-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2016
• Initial Date FDA Received: 09/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• 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