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

Lot Number C710-KIT

Device Problems Kinked (1339); Vibration (1674); Device Displays Incorrect Message (2591); Moisture or Humidity Problem (2986); Noise, Audible (3273)

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

Event Date 07/14/2014

Event Type  malfunction  

Event Description

Customer called to report system error f183:0000.Css asked customer to check for leaks at the centrifuge bowl.Css asked if there were any alarms during treatment.Customer stated there was an empty ac alarm during prime and he noticed there was a kink immediately below the ac drip chamber.Customer positioned and taped the line to reduce the kink.Customer stated he received no pressure alarms during treatment.Collect rate was 17-20 ml/min with a vortex port.Customer stated during the 6th draw cycle, he heard a sound as if the centrifuge motor was straining and/or vibrating.Customer noticed a slight kink in the centrifuge bowl inlet line which he corrected by positioning and taping the line.Customer stated he manipulated the top of the bowl to reduce the noise, but when he took his hand off of the bowl, the noise resumed.Customer stated he then saw humidity on the centrifuge lid which was followed by a blood leak alarm.Css asked the customer to remove the bowl to inspect for moisture, and ensure the inlet and outlet lines attached to the bowl were secure.Customer did not see any leaks.Customer reseated the bowl and resumed treatment.Instrument immediately displayed a blood leak alarm.Css recommended aborting the treatment but to consult with the provider if a manual blood return is preferred.Customer chose to abort treatment.Pt was stable.Customer agreed to return the used kit for investigation.

Manufacturer Narrative

A review of lot c710 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 trend has been detected for leak centrifuge alarm; mfr's capa (b)(4) is already opened to investigate empty anticoagulant alarms.The assessment is based on info available at the time of the investigation.The product returned investigation is still in progress at the time of this report; therefore, final investigation findings are still pending.(b)(4).

• Brand Name: THERAKOKS 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: 4219078
• MDR Text Key: 4971422
• Report Number: 2523595-2014-00206
• 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: 07/14/2014

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: C710-KIT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2014
• Initial Date FDA Received: 08/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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: 51 YR
• Patient Weight: 92