MAUDE Adverse Event Report: THERAKOS, INC UVAR XTS PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Device Alarm System (1012); Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 02/24/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction: photoactivation module leak.The complaint category photoactivation module leak is associated with the kit; therefore, a mdr against the kit was filed to fda for this case.A batch record review for kit lot e727 was conducted.There were no non-conformances.This lot met all release requirements.A review of kilt lot e727 for the reported complaint issue shows no trends.Trends were reviewed for complaint category, photoactivation module leak.No trends were detected for this complaint category.A kit analysis was conducted for this complaint.A review of the returned photoactivation module for the xts kit verified that there was a leak at the bond between the outlet line and the port on the photoactivation module.The root cause of the failure was determined as due to an operator error during tube bonding while assembling the kit.Operators' re-training was performed at the manufacturing site.Investigation completed.(b)(4).

Event Description

Customer called to report there was fluid leaking from photoactivation plate during buffy coat collection of the second cycle.Customer noted there may be a crack in the photoactivation plate.The customer also stated there was no fluid leak during priming phase or buffy coat collection of cycle one.The treatment was aborted with no return of blood products to the patient.Customer stated there were no alarms prior to noticing the blood leak and that no one was splashed with fluids or injured.Customer reported patient was stable.Customer will return kit for investigation.

• Brand Name: UVAR XTS PHOTOPHERESIS SYSTEM
• Type of Device: UVAR XTS PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC; 10 north high street; suite 300; west chester PA 19380
• Manufacturer (Section G): THERAKOS; 53 frontage drive po box 9001; hampton NJ 08827
• Manufacturer Contact: megan vernak ; 53 frontage drive po box 9001; hampton, NJ 08827
• MDR Report Key: 6423908
• MDR Text Key: 70881033
• Report Number: 2523595-2017-00054
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200027
• UDI-Public: (01)20705030200027(10)E727(17)210701
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/22/2017

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: 07/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: XT125
• Device Lot Number: E727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2017
• Initial Date FDA Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2016
• 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
• Patient Age: 69 YR
• Patient Weight: 59