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

Lot Number C357/386

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/31/2015

Event Type  malfunction  

Event Description

Customer called to report blood leak during a double-needle mode treatment at 1543ml processed.10 thousand unit heparin used at 10:1.Picc lines for access.Customer stated the drive tube bearings were still in the holder, but it appeared that the drive tube cracked.Customer stated the leak detector strip was intact.Customer stated on-site biomedical engineer was tending to the instrument.There was no service order generated.The customer returned pictures and the kit for investigation.

Manufacturer Narrative

A batch record review of lot c357 was performed.There were no nonconformances associated with this lot.This lot met release requirements.Trends were reviewed for complaint categories, alarm #7: blood leak (centrifuge chamber?) and drive tube leak/break.No trends were detected.A capa was initiated for drive tube leak/breaks.The kit, smart card, and photographs were returned for analysis.Review of the smart card data confirmed the occurrence of a blood leak (centrifuge) alarm.Review of the returned kit components found that the upper bearing stop had been moved out of position on the drive tube indicating it had delaminated.The root cause of the reported leak is delamination of the bearing stop from the drive tube.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.Review of the device history record did not identify any related nonconformances.Therakos and the manufacturer have initiated capas to address several potential root causes of this issue.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYETEM
• 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: 4691767
• MDR Text Key: 5710836
• Report Number: 2523595-2015-00101
• 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
• Report Date: 03/31/2015

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: 11/01/2016
• Device Lot Number: C357/386
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2015
• Initial Date FDA Received: 04/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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 Weight: 37