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

Lot Number C712-KIT

Device Problem Fluid/Blood Leak (1250)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 07/07/2014

Event Type  malfunction  

Event Description

Customer called and reported blood leak alarm after start of the first cycle.Customer found a leak at the bottom of the bowl.Customer tried to put out the blood out of the centrifuge chamber.Physician took photos of the damaged bowl and will send for investigation.Customer asked for service to check the machine after the leak.Treatment was aborted and will be done next day.Patient info: platelet count: 258000, ac: before treatment: 500 i.U.Heparin in 5ml saline injection, 10000 i.U.Heparin in 500 ml saline, ratio 10:1.Access: pakumed-port, port needle 17g.Service order (b)(4) was dispatched.Customer provided photos for investigation.

Manufacturer Narrative

A review of lot c712 was conducted.There were no non-conformances associated with this lot.The lot met release requirements.Trends have been reviewed for this complaint category and no trends have been detected for drive tube leak/ breaks; manufacturer's capa ((b)(4)) is already opened to investigate centrifuge bowl leak/breaks.Service order (b)(4) feedback is still pending.The assessment is based on info available at the time of the investigation.The photo evaluation is still in progress at the time of this report; therefore, final investigation findings are still pending.(b)(4).

• Brand Name: THERAKOS XTS SYSTEM
• Type of Device: XTS
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 e, ste 140; bridgewater, NJ 08807
• MDR Report Key: 4121536
• MDR Text Key: 4941206
• Report Number: 2523595-2014-00196
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P680003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/07/2014

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: 03/01/2019
• Device Lot Number: C712-KIT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2014
• Initial Date FDA Received: 07/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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 Weight: 58