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

Lot Number C145-KIT

Device Problems Bent (1059); Break (1069); Detachment Of Device Component (1104); Fluid/Blood Leak (1250); Cut In Material (2454); Device Displays Incorrect Message (2591)

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

Event Date 04/10/2015

Event Type  malfunction  

Event Description

The customer called and reported a drive tube break with a blood leak alarm from a treatment on the same day.The treatment was aborted and the patient had already left at the moment of call.The incident occured at 1315 ml of whole blood processed.The upper metallic ring had left its retainer, however the nurse was sure that the kit was well installed and that the bearings were well attached in their retainers.The tubing was bent and cut above this.No other alarms were reported.The centrifuge leak detector was broken.The treatment was aborted, and the patient was reported to be in stable condition.Service orders ,(b)(4), (b)(4), and (b)(4) were dispatched to change the centrifuge leak detector and to clean the instrument.Photos were returned for evaluation.

Manufacturer Narrative

The device was used for treatment.This case is being reported as a possible malfunction.A batch record review of lot c145 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.The uvadex lot number was not provided; therefore, a batch record review could not be performed.Trends were reviewed for complaint categories, alarm #7: blood leak (centrifuge chamber) and drive tube leak/break.No trends were detected for these complaint categories.A corrective and preventive action (capa) was initiated for complaint category, drive tube leak/break.No capa was initiated for complaint category, alarm #7: blood leak (centrifuge chamber).Service order, (b)(4), feedback: the service technician cleaned the instrument and checked the index pulse alignment.The technician also ordered a new leak detector strip.Service order, (b)(4), feedback: the service technician removed and cleaned the interior door panel, the centrifuge support bowl, the connector tubing, and the bowl retainer within the centrifuge chamber.The technician also replaced the leak detector.The technician then successfully performed the system checkout procedure.The following day the service technician did another complete cleaning of the centrifuge.Service order, (b)(4), feedback: the service technician removed the door and found the presence of blood under the glass.The technician did a through cleaning and inspection of the entire door.The technician performed a hydrogen peroxide test on the door after cleaning the door, and did not detect any traces of blood.He then successfully performed the system checkout procedure.No further action required.Product return feedback: a photo analysis was conducted for this complaint.Review of the customer supplied photographs confirmed that a leak occurred.In the photos, the drive tube had twisted, and the center section of the upper bearing had separated from the rest of the bearing.However, the actual leak site was not determined.The leak was likely caused by either the twisting of the drive tube or the impact of the drive tube on the centrifuge chamber wall.The analysis was unable to determine the root cause of the failed bearing.Review of the device history record did not identify any related nonconformances.No manufacturing defects could be determined through the evaluation of the customer supplied photographs.The assessment is based on information available at the time of the investigation.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).Not returned to manufacturer.

• 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: 4743731
• MDR Text Key: 5773272
• Report Number: 2523595-2015-00137
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/10/2015

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: C145-KIT
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2015
• Initial Date FDA Received: 05/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 44 YR