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

Lot Number C733 - KIT

Device Problem Fluid/Blood Leak (1250)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 07/31/2014

Event Type  malfunction  

Event Description

Customer called to report blood leaking from the hematocrit sensor.Customer noted the leak during the collection of the first buffy boat.Customer stated she aborted the procedure and did not return any blood or products to the patient.Css asked if anyone was splashed with any blood/fluid due to ther splash.Customer stated no one was splashed.Css asked if there were an alarms, customer stated there were no alarms.Css asked if patient was okay, customer stated patient is asymptomatic.Customer will return the kit for investigation.Service order (b)(4) was dispatched.

Manufacturer Narrative

A review of lot c733 could not be conducted, as the lot number provided by reporter is not a valid not number.Trends have been reviewed for this complaint category and no trends have been detected for tubing leak; capa (b)(4) was already opened to investigate this type of events.Service order (b)(4) completed: service engineer ran system checkout procedure; adjusted hct sensor; no further action required.The assessment is based on information available at the time of the investigation.The product return has not yet been received for investigation 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 MEDICAL PRODUCTS; 2201 baily ave.; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east; ste 140; bridgewater, NJ 08807
• MDR Report Key: 4058965
• MDR Text Key: 4807411
• Report Number: 2523595-2014-00219
• 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: 07/31/2014

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 Lot Number: C733 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2014
• Initial Date FDA Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 42 YR
• Patient Weight: 78