MAUDE Adverse Event Report: THERAKOS INC. CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591); Noise, Audible (3273)

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

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunctions drive tube leak/break and pressure dome membrane leak.Since these reportable malfunctions are only associated with the kit, this mdr will only be against the kit.A batch record review for kit lot g362 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot g362 shows no trends.Trends were reviewed for complaint categories, drive tube leak/break and 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 returned kit and photographs is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

The customer called to report a drive tube leak/break and pressure dome membrane leak that occurred during a treatment.The customer explained that a system pressure alarm occurred 2 - 3 minutes into the procedure.Shortly after, a loud "clang" was heard from the centrifuge chamber and the treatment was stopped immediately.Inspection of the centrifuge chamber identified that the drive tube had severed just above the drive tube clamp.In addition, a leak was observed around the system pressure dome.The customer stated that approximately 100 mls of whole blood was processed at the time the break occurred.The treatment was aborted and the patient was reported to be in stable condition.The patient was able to receive treatment on the same instrument without issue.The customer returned the kit and photographs for investigation.

Manufacturer Narrative

The customer returned the kit and photographs for investigation.A review of the photographs confirmed that a blood leak took place at the system pressure dome during treatment and that the drive tube broke.The drive tube twisted about its length and broke above the lower overmold and below the lower bearing stop.Both of the bearings were still connected to the drive tube.The bearings rotated freely and showed no signs of damage.The damage to the drive tube may have been the result of a misload.Inspection of the received kit confirmed the leak from the system pressure dome.The diaphragm of the system pressure dome was partially unseated and there was blood on the underside of the pressure dome.The pressure dome was installed on a test instrument and was pressure tested.Testing did not find an issue with the system pressure dome.The leak at the pressure dome may have been the result of an improperly seated pressure dome.The root cause for the pressure dome leak and the drive tube break could not be determined.No further action is required at this time.This investigation is now complete.Mc (b)(4).S.D.A.03/29/2019.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS INC.; bedminster NJ 07921
• MDR Report Key: 8383392
• MDR Text Key: 138102034
• Report Number: 2523595-2019-00027
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G362(17)200901
• Combination Product (y/n): N
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Date Manufacturer Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR