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

Lot Number C739

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371); Device Displays Incorrect Message (2591)

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

Event Date 01/21/2015

Event Type  malfunction  

Event Description

Customer reported that after the procedure was finished, the flm was opened and a small amount of blood was leaking from the flm.The operator reported that an air detected alarm happened early in the procedure due to a loose connection on the patient line and a patient occlusion alarm happened shortly after that alarm because the line was kinked.The operator reported that she would routinely do a manual blood return to return the residual volume in the kit, but did not do that this time because of the leak.The customer returned the kit for investigation.Update, (b)(4) 2015: customer's therakos xts -trained biomed called and reported they had found the leak seemed to be at one of the tubing ports at the top of the flm, and that they had estimated 2-3 cc of blood had leaked.Biomed started that after removing the side panels around the blood pump, very little blood was found near the blood pump membrane, but he intends to order a replacement blood pump membrane.Css advised him to ensure no blood had been pulled through the membrane vents into the blood pump.No service order was generated.The kit was returned for investigation.

Manufacturer Narrative

A review of lot c739 was performed and there were no nonconformances associated with this lot.This lot met release requirements.Trends were reviewed for complaint categories, flm leak, air detected alarm, or occlusion patient alarm.No trends were detected.No capas have been initiated for these complaint categories.The assessment is based on information available at the time of the investigation.Evaluation of the returned kit is still in progress at the time of this report.A supplemental report will be filed when this evaluation is complete.(b)(4).

• Brand Name: THERAKOS XTS PHOTOPHERESIS 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, suite 140; bridgewater, NJ 08807
• MDR Report Key: 4494167
• MDR Text Key: 5345383
• Report Number: 2523595-2015-00027
• 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: 01/21/2015

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: 07/01/2019
• Device Lot Number: C739
• Other Device ID Number: 10705030100016
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/29/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2015
• Initial Date FDA Received: 02/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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: 87