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

Lot Number C721-KIT

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2014

Event Type  malfunction  

Event Description

Customer and clinical service educator reported: a blood leak occurred at the bowl seal at the beginning of cycle two buffy collect.Two system occlusion alarms had been reset earlier in the treatment.There was a white substance visible in the exit port of the bowl and in the plasma bag; the nurse, the clinic service educator (cse), and the physicians in the room could not determine what the white substance was by visual observation, so a sample is being sent to their lab for analysis.Customer described the white substance as appearing like "crisco." the patient's plasma was clear.The treatment was aborted when the blood leak occurred and none of the blood in the kit and that time was returned to the patient.Patient is stable.Service (b)(4) was dispatched.This disposable kit was not returned for evaluation.

Manufacturer Narrative

A review of lot c721 was conducted.There were no nonconformances associated with this lot.The lot met release requirements.Trends have been reviewed for this complaint category and no trends have been detected for centrifuge bowl leak; manufacturer's capa ((b)(4)) has already been initiated to investigate centrifuge bowl leaks.Service order (b)(4) completed: service engineer ran centrifuge for 20 minutes, cleaned leak detector & centrifuge with alcohol; performed system checkout.The assessment is based on information available at the time of the investigation.The product return has not yet been received at the time of this report; therefore, final investigation findings are still pending.

• 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 east; suite 140; bridgewater, NJ 08807
• MDR Report Key: 4174591
• MDR Text Key: 20068052
• Report Number: 2523595-2014-00209
• 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: 07/15/2014

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: 04/01/2019
• Device Lot Number: C721-KIT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2014
• Initial Date FDA Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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 Age: 95 YR
• Patient Weight: 54