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

Lot Number B706-KIT

Device Problems Leak/Splash (1354); Material Separation (1562)

Patient Problem Blood Loss (2597)

Event Date 03/19/2014

Event Type  malfunction  

Event Description

Customer called to report the tubing entering and exiting the centrifuge bowl on came apart and there was a blood leak at the end of the patient treatment when the customer was performing the manual return of the residual kit volume, estimated blood loss is about 100ml, of which 40-50ml is established to be red blood cells.Customer decided this was not going to adversely affect the patient and would not return the residual blood volume to the patient.The customer reported that the patient was stable.Css advised the customer to thoroughly inspect the kits while installing them, and if any part of the kit is not up to the therakos standards, to not use the kit.The customer's concern is expected to be resolved by the phone assistance provided and recorded in this record or customer has agreed to call back.No product was returned by the customer for investigation.

Manufacturer Narrative

Batch record review of lot b706 was conducted.There were no non-conformances associated with this lot.Lot met release requirements.Trends have been reviewed for this complaint category and no trend has been detected for any lot.No product was returned by the customer for investigation.Therefore, a root cause cannot be determined based solely on the information provided by the customer.Complaints of this nature are monitored through tracking and trending.Should a trend arise, further action will be taken.

• Brand Name: THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM
• Type of Device: XTS
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey avenue; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east; suite 140; bridgewater, NJ 08807
• MDR Report Key: 3880912
• MDR Text Key: 4509946
• Report Number: 2523595-2014-00107
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P680003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/19/2014

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: 02/01/2018
• Device Lot Number: B706-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2014
• Initial Date FDA Received: 04/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• 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