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

Lot Number C736 - KIT

Device Problems Leak/Splash (1354); Device Displays Incorrect Message (2591); Moisture or Humidity Problem (2986); Noise, Audible (3273)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/23/2014

Event Type  malfunction  

Event Description

Customer reported a blood leak alarm had occurred during cycle 6 with a 125 ml bowl kit.Customer reported the blood leak was not easily visible, but some moisture was apparent on a glove used to check for a leak.Customer reported there was also a grinding noise from the bowl, and a system error f183 occurred when they had tried to resume the treatment.Customer reported that they aborted the procedure and did not return blood/products to the pt.Pt was in stable condition.Customer stated they will return the kit for investigation.No service order was generated.

Manufacturer Narrative

A review of lot c736 was conducted and there were no nonconformities related to this type of event.This lot met release requirements.Trends were reviewed for complaint categories.Centrifuge bowl leak/break, noise, system error f183: centrifuge speed too slow, and leak centrifuge alarm and a downward trend was detected for centrifuge bowl leak/break.No trends were detected for complaint categories, noise system error f183: centrifuge speed too slow, and leak centrifuge alarm.Mfr (b)(4) was initiated for complaint category, centrifuge bowl leak/break.This assessment is based on info available at the time of the investigation.Therakos has not yet received the kit from the customer at the time of this report; therefore, final investigation findings are still pending.(b)(4).

• Brand Name: THERAKOS XTS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MED PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east, ste 140; bridgewater, NJ 08807
• MDR Report Key: 4289437
• MDR Text Key: 21527295
• Report Number: 2523595-2014-00296
• 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: 10/23/2014

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: 06/01/2019
• Device Lot Number: C736 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2014
• Initial Date FDA Received: 11/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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: 60 YR
• Patient Weight: 90