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

Lot Number C312-KIT

Device Problems Kinked (1339); Leak/Splash (1354); Device Displays Incorrect Message (2591)

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

Event Date 06/02/2014

Event Type  malfunction  

Event Description

Customer called to report leak from pump tubing organizer at the start of procedure.Customer started treatment procedure and got blood pump alarm.Customer noted a slight kink in the collect pump tubing, so customer turned the collect pump tubing to clear the alarm.Customer also pressed down on the pump tubing organizer, to assure it was down completely.Customer pressed start and noted saline leaking onto the pump deck by the return pump and filter.Customer stated there was no blood leaking onto pump deck, it was priming fluid.Customer stated the bowl was still filling up so there was no blood in the filter yet.Customer stated treatment was aborted and no product was returned to the patient.Customer stated kit has been removed and she was priming a new kit.Customer stated patient's condition was stable.No service order was generated.The kit was not returned for investigation, however, a picture was received for analysis.

Manufacturer Narrative

Batch record review of lot c312 was conducted.There were no nonconformances associated with this lot.The lot met release requirements.Trends were reviewed for complaint categories, pto leak and alarm #9: blood pump error.No trend was detected for complaint categories, pto leak and alarm #9: blood pump error.(b)(4) were initiated for complaint category, pto leak.A photo analysis was conducted for this complaint.The photo shows the kit pump tubing organizer with saline droplets on the inside.The tubing is bonded to various connectors and is routed through the pump tubing organizer.Once complete, all kits are subjected to leak and occlusion test for the finished kit.Based on the attached photo and complaint description, it could not be determined if the product met specifications.However a dhr review confirmed all parts met specification.Complaints of this nature are monitored through tracking and trending.Should a trend arise further action will be taken.Capa (b)(4) is currently opened, pending implementation, to investigate late medwatch submission.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave.; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east, suite 140; bridgewater, NJ 08807
• MDR Report Key: 4128755
• MDR Text Key: 4922556
• Report Number: 2523595-2014-00257
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P680003
• 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: 06/02/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2016
• Device Lot Number: C312-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2014
• Initial Date FDA Received: 09/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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: 19 YR
• Patient Weight: 66