MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICBLE

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

Patient Problems Virus (2136); No Known Impact Or Consequence To Patient (2692)

Event Date 03/11/2020

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 malfunction is only associated with the kit, this mdr will be against the kit.A batch record review for kit lot h134 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h134 shows no trends.Trends were reviewed for complaint categories, alarm #18: system pressure, alarm #19: fluid balance limit, and pressure dome membrane leak.No trends were detected for these complaint categories.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).

Event Description

The distributor emailed to report a pressure dome membrane leak that occurred with a cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment procedure.The distributor stated that an alarm 18: system pressure alarm occurred near the end of the patient's ecp treatment procedure.The distributor reported that the customer then noticed a leak at the system pressure dome.The distributor stated that an alarm #19: fluid balance limit alarm occurred after the alarm #18: system pressure alarm.The distributor reported that the patient's fluid balance was positive.The distributor stated that the patient's ecp treatment was completed with both blood and uvadex treated cells returned to the patient.The distributor reported that all of the patient's scheduled ecp treatment procedures have been canceled due to the covid 19 situation.Although requested, no product was returned for investigation.

Manufacturer Narrative

The smart card was returned for evaluation.Based on the smart card data the kit lot number involved in this case was kit lot h140.Corrected: d4 and h4.A batch record review for kit lot h140 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h140 shows no trends.The smart card data was reviewed.Prime was completed without incident and blood collection began.Two alarm #18: system pressure alarms then occurred due to pressure at -9 mm hg after 109 ml and 164 ml of whole blood processed.Following the second alarm #18: system pressure alarm, an alarm #4: centrifuge chamber door alarm occurred and the customer opened and then closed the centrifuge door.The treatment continued as expected with the completion of the buffy collection and photoactivation.The uvadex treated cells were also fully reinfused to the patient.An alarm #53: return line air detected alarm occurred during the reinfusion of the remaining fluid within the return bag.Several alarm #19: fluid balance alarms then occurred as the patient's fluid balance (501 ml) was over the device's preset fluid balance limits of + / - 500 ml.The customer then powered off the device.The smart card review confirmed the reported alarm #18: system pressure and alarm #19: fluid balance alarms; however, the root cause for these alarms could not be determined based on the available information.The smart card investigation could not confirm the occurrence of a pressure dome membrane leak.No further action is required at this time.The investigation is complete.(b)(4).S.K.6/25/2020.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• MDR Report Key: 9943930
• MDR Text Key: 198757733
• Report Number: 2523595-2020-00052
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/25/2020

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Model Number: NOT APPLICBLE
• Device Catalogue Number: CLXECP
• Device Lot Number: H140
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/13/2020
• Initial Date FDA Received: 04/09/2020
• Supplement Dates Manufacturer Received: 05/27/2020
• Supplement Dates FDA Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0