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

Device Problems Thermal Decomposition of Device (1071); Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 08/01/2014

Event Type  malfunction  

Event Description

Customer called to report a spark which occurred 'sometime last week' when the nurse plugged the instrument into the wall.Customer stated there is a burn mark on the power cord.Field engineer was on-site and encouraged the customer to call about the incident.Customer thought it would be managed by the institution's electrical svc personnel initially, and that is why she didn't report it to clinical svc specialist earlier.Instrument has been taken out of svc.There was no kit installed on the instrument when the incident occurred and no pt involvement.Svc order: (b)(4) was dispatched.

Manufacturer Narrative

Trends have been reviewed for complaint categories, fire, and damaged parts/ components, and no trends have been detected these complaint categories.There was no kit installed on the instrument when the incident occurred; therefore, no kit batch record review was performed.This assessment is based on info available at the time of the investigation.Svc order feedback is still pending at the time of this report.A final report will be submitted when this feedback is received.

• Brand Name: THERAKOS XTS PHOTOTPHERESIS SYSTEM
• Type of Device: XTS
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MED PRODUCTS; 2201 baily ave; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 e; ste 140; bridgewater, NJ 08807
• MDR Report Key: 4097964
• MDR Text Key: 4836174
• Report Number: 2523595-2014-00232
• 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: 08/19/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2014
• Initial Date FDA Received: 09/08/2014
• 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