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

Model Number NOT APPLICABLE

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 02/21/2019

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 g369 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g369 shows no trends.Trends were reviewed for complaint categories, tubing leak, alarm #1: air detected.No trends were detected for each 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 smartcard is still in progress.A supplemental report will be filed when the analysis is complete.Mc: (b)(6).P.T.(b)(6) 2019.

Event Description

The customer called to report a tubing leak during the treatment procedure.The customer stated they received an alarm #1: air detected alarm during the procedure and noted air in the return line.The customer stated they performed a saline bolus into a separate receptacle to clear the air from the line when they noticed blood leaking from the collect pump tubing.The customer aborted the procedure and did not return blood to the patient.The customer stated they patient was stable and started a new procedure.The customer has returned the kit and smartcard for investigation.

Manufacturer Narrative

The complaint kit and smart card were returned for investigation.A review of the smart card data determined that there were no air detected alarms received during the procedure as reported by the customer.The smart card data showed that three alarm #18: system pressure alarms occurred during the treatment.A visual inspection of the returned kit identified evidence of a scuff on the collect pump tubing segment.The tubing segment was pressure tested and confirmed a leak at the site of the scuff.The damage to the tubing is consistent with damage caused during installation of the pump loop tubing into the pump head.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 collect pump tubing segment was damaged prior to product release as an in-process leak test is performed on all cellex kits prior to packaging.The investigation determined that the tubing leak most likely 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.04/04/2019.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 8445848
• MDR Text Key: 139855768
• Report Number: 2523595-2019-00039
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G369(17)201001
• 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: 04/04/2019

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: 10/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Initial Date Manufacturer Received: 02/21/2019
• Initial Date FDA Received: 03/22/2019
• Supplement Dates Manufacturer Received: 03/06/2019
• Supplement Dates FDA Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 33 YR