MAUDE Adverse Event Report: THERAKOS, INC XTS PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot e726 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot e726 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories, leak centrifuge alarm and centrifuge bowl leak/break.No trends were detected for these complaint categories.This assessment is based on information available at the time of the investigation.At the time of this report, the analysis of the returned kit photo is still in progress.A supplemental report will be filed when the analysis of the kit photo is complete.(b)(4).

Event Description

The customer called to report a leak centrifuge alarm and a centrifuge bowl leak/break.The customer stated that the kit was installed per the operator's manual and there were no alarms or issues noted during prime.The customer reported that immediately after initiating the patient's treatment, a leak centrifuge alarm occurred.The customer stated that a centrifuge bowl leak was then observed and it appeared to be dripping out from the bottom of the centrifuge bowl.The customer reported that the leak had filled the centrifuge chamber.The customer stated that the treatment was aborted with no blood/products returned to the patient.The customer reported that the estimated volume loss for the patient was 20ml.The customer stated that the patient was in stable condition and no medical intervention was required.The customer reported that a new treatment was started for the patient on another instrument.The customer stated that the patient's new treatment was uneventful and the patient continued to be fine.Photos were submitted for investigation.

Manufacturer Narrative

A photo analysis was conducted for this complaint.A review of the photo confirmed the centrifuge bowl leak, however, the site of the centrifuge bowl leak could not be determined based on the information available.The complaint that the centrifuge bowl broke could not be confirmed based only on the photo.The root cause for the leak could not be determined based on the information provided.A review of the device history record did not identify any related nonconformances and this kit lot had passed all lot release testing.No further action required.This investigation is now complete.Device manufacture date: 06/28/2016.(b)(4).Device not returned to manufacturer.

• Brand Name: XTS PHOTOPHERESIS SYSTEM
• Type of Device: XTS PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC; hampton NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; po box 9001; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 6224301
• MDR Text Key: 64177229
• Report Number: 2523595-2017-00002
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200027
• UDI-Public: (01)20705030200027(10)E726(17)210601
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/04/2017

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: Nurse
• Device Expiration Date: 06/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: XT125
• Device Lot Number: E726
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 01/04/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2016
• 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: 28 YR
• Patient Weight: 85