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

Lot Number D309/636 - KIT

Device Problems Crack (1135); Leak/Splash (1354); Device Contamination with Body Fluid (2317); Device Displays Incorrect Message (2591)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/03/2015

Event Type  malfunction  

Event Description

Customer reported a system pressure alarm had occurred when the double needle mode treatment had reached about 650 ml whole blood processed, then she noticed a blood leak had occurred in the centrifuge.Customer stated no other alarms had occurred.Css advised customer to abort the treatment without returning blood in the kit to the patient.Customer reported the patient is stable.After the patient had left the room, the customer opened the centrifuge door to inspect the leak.Customer reported the bowl and drive tube were still properly loaded in the centrifuge.Customer reported the leak sensor strip had blood contamination, but did not appear to be damaged.Customer reported there was some dried blood on the drive tube, and there appeared to be a crack in the drive tube, near the black line, between the two drive tube bearings, and she reported this area felt rough.Service order, (b)(4), was dispatched to complete a thorough cleaning and instrument check out.The customer returned the kit for investigation.

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot d309 was performed.There were no nonconformances related to the complaint.This lot met release requirements.The uvadex lot number was not provided, as it was not used.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 categories, drive tube leak/break and alarm #18: system pressure.No trends were detected for drive tube leak/break and a downward trend was detected for alarm #18: system pressure.A corrective and preventive action was initiated for complaint category, drive tube leak/break.No corrective and preventive action was initiated for alarm #18: system pressure.Service order, (b)(4), was completed.The service technician cleaned blood from the centrifuge area and centrifuge plate.The return pump was calibrated and the system checkout procedure was performed.No further action required.This assessment is based on information available at the time of the investigation.Evaluation of the returned kit is still in process at the time of this report.A supplemental report will be filed when this analysis has been completed.(b)(4).

Manufacturer Narrative

The kit, smartcard, and photos were returned for analysis.Several return pressure alarms, system pressure alarms and a blood leak centrifuge alarm were seen.The 685ml of whole blood was processed.Review of the returned kit confirmed the leak was due to upper bearing stop delamination, as the upper bearing stop could be moved along the axis of the drive tube.The manufacturer indicated that there was a cut/leak in the drive tube halfway between the bearing stops.The bearing stop delamination allowed the drive tube to rub against the wall of the centrifuge chamber, damaging the drive tube and causing a leak.Therakos and the manufacturer have initiated corrective actions to address potential root causes of drive tube and bearing stop delamination.Complaints are monitored through tracking and trending.Should a trend arise, further action will be taken.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS 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: 4859883
• MDR Text Key: 19738752
• Report Number: 2523595-2015-00185
• Device Sequence Number: 1
• Product Code: LNR
• 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 Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/03/2015

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: 02/01/2017
• Device Lot Number: D309/636 - KIT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2015
• Initial Date FDA Received: 06/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• 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: 37 YR
• Patient Weight: 107