MAUDE Adverse Event Report: THERAKOS, INC. THERAKOS CELLEX PHOTOPHORESIS SYSTEM

Lot Number C359-KIT

Device Problems Leak/Splash (1354); Material Twisted/Bent (2981)

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

Event Date 01/29/2015

Event Type  malfunction  

Event Description

The customer reported a drive tube blood leak which occurred when the single needle mode treatment had reached 1401 ml whole blood processed (wbp).The customer aborted the treatment without returning the blood in the kit at that time to the patient.The customer reported that the leak appeared to be coming from a split in the drive tube, at about a 45 degree angle, next to the upper drive tube bearing.The drive tube appeared to be twisted about one-half of a turn.The customer reported that the drive tube was still clamped into the bearing retainers when the treatment was aborted, and that the centrifuge leak sensor strip did not appear to have been damaged.The customer reported a system pressure alarm had occured at about the time of the leak.The customer did not know if a leak alarm had occurred.The customer reported other alarms that occured earlier in the treatment.A red blood cell pump alarm occurred at 400 wbp which had been resolved by stopping, starting, and slowing the collect rate, and a return pressure alarm which was resolved early in the treatment, which had been caused by patient movement.15000 units of heparin in 500 ml saline was used as the anticoagulant in this treatment.The patient was reported to be in stable condition.Service order, (b)(4), was generated and the kit along with photos were returned for evaluation.

Manufacturer Narrative

A batch record review of lot c359 was conducted.There were no nonconformances associated with this lot.The lot met release requirements.Trends were reviewed for complaint categories, drive tube leak/break, alarm #18: system pressure, alarm #45: red blood cell pump alarm and alarm #17: return pressure.No trends were detected for complaint categories, drive tube leak/break and alarm #17: return pressure.An upward trend was detected for complaint categories, alarm #18: system pressure and alarm #45: red blood cell pump alarm.Drive tube leak/break was investigated through capa (b)(4) and capa (b)(4).Capa (b)(4) was closed.Alarm #18: system pressure, alarm #45: red blood cell pump alarm, and alarm #17: return pressure were investigated through capa (b)(4).Capa (b)(4)was closed.Alarm #18: system pressure and alarm #45: red blood cell pump alarm were also investigated through capa (b)(4).Capa (b)(4) was closed.Service order, (b)(4), feedback: the customer had cleaned the machine and the service technician cleaned the surfaces where blood commonly pools such as behind the panels and such.The technician performed the checkout procedure and all tests passed per specifications.The technician also adjusted the pressure transducers and load cells per documentation.The technician tested the machine and no errors were found.No further action required.This assessment is based on information available at the time of the investigation.The kit and photos were returned for evaluation.Analysis of the kit and photos is in progress.A supplemental report will be filed when this analysis is completed.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHORESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC.; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave.; buffalo NY 14211
• Manufacturer Contact: 10 north high st.; suite 300; west chester, PA 19380
• MDR Report Key: 4535784
• MDR Text Key: 18091937
• Report Number: 2523595-2015-00043
• 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: 01/29/2015

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: Health Professional
• Device Expiration Date: 11/01/2016
• Device Lot Number: C359-KIT
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2015
• Initial Date FDA Received: 02/20/2015
• 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 Age: 75 YR
• Patient Weight: 66