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

Model Number NOT APPLICABLE

Device Problems Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923)

Patient Problem Blood Loss (2597)

Event Date 05/16/2019

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction tubing leak.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.A batch record review for kit lot g383 was conducted.There were no non-conformance's related to the complaint.This lot met all release requirements.A review of kit lot g383 for the reported issue shows no trends.Trends were reviewed for complaint category, tubing leak.No trends were detected for this complaint category.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 smart card 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 tubing leak during the treatment procedure.The customer stated a blood leak was observed from the return pump tubing segment after approximately 1438 ml of whole blood had been processed.The customer stated the pump tubing organizer (pto) was not locked down into position and had appeared to have popped up.The customer aborted the procedure and did not return blood to the patient.The customer stated the patient was stable.The customer has returned the kit and smart card for investigation.

Manufacturer Narrative

The complaint kit and smart card were returned for investigation.A review of the data recorded on the smart card showed prime was completed and blood collection started in single needle mode.The treatment proceeded until a centrifuge pause warning occurred after the operator pressed the pause button.The data shows approximately 1438 ml of whole blood had been processed when the operator aborted the treatment.Examination of the received kit found dried blood on the bottom of the pump tubing organizer (pto), below the filter and return pump tubing segment.The return pump tubing segment was pressure tested and verified a leak from the inlet side of the tubing segment.Further examination found a small cut in the return pump tubing segment.The pto was installed onto a test instrument to assess its fit.The pto fit onto the pump deck of the test instrument without issue and all latches successfully locked into position.The occluders on the instrument were activated to apply upward force onto the pto, there were no signs of the pto becoming unsecured.The customer report of the pto popping up during the treatment could not be verified or recreated.The damage to the tubing is at the location where there is an edge on the instrument pump head.The size, shape, and location of the observed damage on the pump loop is consistent with damage that occurs if the pump loop tubing is rubbed against the pump head during installation by the end user.If the pump loop is forcefully rubbed against the pump head during installation of the kit, it could potentially result in scraping and/or cutting of the tubing loop as the pump head rotates.It is unlikely the return pump tubing segment was damaged prior to product release as an in-process leak test is performed on all cellex kits prior to packaging.A material trace of the tubing used to manufacture kit lot g383 showed no nonconformities.A device history record review did not identify any related nonconformities and this kit lot had passed all lot release testing.The investigation determined that the root cause of the tubing leak was most likely caused by damage that occurred during installation of the pump loop.No manufacturing related defects were identified through this investigation.No further action is required at this time.This investigation is now complete.Mc: (b)(4).P.T.07/12/2019.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 8697245
• MDR Text Key: 148289556
• Report Number: 2523595-2019-00065
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G383(17)201101
• 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: 07/12/2019

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: Health Professional
• Device Expiration Date: 11/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 06/13/2019
• Supplement Dates Manufacturer Received: 07/09/2019
• Supplement Dates FDA Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 74