MAUDE Adverse Event Report: THERAKOS INC. THERAKOS CELLEX PHOTOPHEREISIS SYSTEM

Lot Number D336/465 - KIT

Device Problems Device Alarm System (1012); Leak/Splash (1354)

Patient Problems Hemorrhage/Bleeding (1888); Hyperglycemia (1905)

Event Date 10/23/2015

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A review of kit lot d336 was performed.There were no nonconformances associated with this lot.This lot met release requirements.The uvadex lot number was not provided, since uvadex was not administered.However, a review of all uvadex lots manufactured since january 2013 was performed.No trends or nonconformances related to the complaint were noted.Trends were reviewed for complaint category, tubing leak.No trends were detected.Service order, (b)(4), was completed.The pump motor and pump head were replaced and system checkout was performed.Analysis of the photos sent by the customer is still in progress at the time of this report.A supplemental report will be filed when this analysis is complete.(b)(4).

Event Description

Customer called to report a blood leak at 733 ml whole blood processed.Customer said that there were no alarms, but a leak in the tubing to the return bag near the air detector started leaking.Treatment was aborted at this point.Patient was stable and was released.Customer requested service.Service order, (b)(4), was generated.The customer returned pictures for investigation.

Manufacturer Narrative

Photos were submitted by the customer for evaluation.Review of the photographs confirmed the reported tubing damage and blood leak; there is a hole or gouge in the return bag tubing line near the air detectors on the pump deck.Review of the device history record did not identify any related nonconformances.Review of the photographs was unable to determine the root cause of the leak.No manufacturing related defects were confirmed during the evaluation.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/continuous improvement process.(b)(4).Device not returned.

• Brand Name: THERAKOS CELLEX PHOTOPHEREISIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS INC.; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave.; buffalo NY 14211
• Manufacturer Contact: dianna inguanzo ; 10 north high street; suite 300; west chester, PA 19380
• MDR Report Key: 5228158
• MDR Text Key: 31573005
• Report Number: 2523595-2015-00278
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: 10705030100009
• 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: 10/23/2015

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: Nurse
• Device Expiration Date: 06/01/2017
• Device Lot Number: D336/465 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2015
• Initial Date FDA Received: 11/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• 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: 88 YR