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

Lot Number C707-KIT

Device Problems Crack (1135); Occlusion Within Device (1423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/08/2014

Event Type  malfunction  

Event Description

Customer called to report blood leak alarm while the instrument was paused in the 3rd cycle.Customer had access problems with the vortex port and stopped the centrifuge to interrupt treatment and instill alteplase into the port.After 30 minutes, nurse came to check the patency of the line, but the port was still occluded.Nurse heard a blood leak alarm.Nurse did not see any leaks.Css instructed the customer's remove the bowl to check thoroughly for moisture.At that time, the nurse's supervisor came in and gave the operator instruction to abort the treatment.Customer called back to state the treatment was aborted and the pt was rescheduled for tomorrow.When the customer went to dispose of the used kit, she noticed a v-shaped crack forwards the top of the bowl which had some dried blood on it.She also noted approx half inch circle of blood at the base of the centrifuge.

Manufacturer Narrative

Batch record review of lot c707 was conducted.There were no non conformances related to this lot.Lot met release requirements.Trends have been reviewed for this complaint category and no trend has been detected, however, manufacturer's capa ((b)(4)) has already been initiated to investigate this type of events.The assessment is based on info available at the time of the investigation.No product was returned for investigation at the time of this report; therefore, it could not be determined if the product met specification based solely on the info provided by the customer.(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 bailey ave; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east; ste 140; bridgewater, NJ 08807
• MDR Report Key: 3908404
• MDR Text Key: 4588021
• Report Number: 2523595-2014-00153
• 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: 05/08/2014

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: 02/01/2019
• Device Lot Number: C707-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2014
• Initial Date FDA Received: 06/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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: 54 YR
• Patient Weight: 103