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

Lot Number C351-KIT

Device Problems Leak/Splash (1354); Device Contamination with Body Fluid (2317)

Patient Problem No Patient Involvement (2645)

Event Date 01/05/2015

Event Type  malfunction  

Event Description

Customer called to report "blood leak (centrifuge chamber)" alarm during a single needle mode procedure.Whole blood 750 ml processed.Customer stated the leak appears to be coming from the bowl, not the drive tube.Customer stated there were no dislodged parts, but she saw blood sprayed inside the centrifuge well.Treatment was aborted.No other alarms were reported for this treatment.Pt was reported to be in stable condition.Service order (b)(4) was dispatched.The customer sent photos for investigation.

Manufacturer Narrative

A review of lot c351 was performed.There were no nonconformities associated with this lot.This lot met release requirements.Trends were reviewed for complaint category alarm #7: blood leak (centrifuge chamber) and centrifuge bowl leak/break.No trends were detected.Capa (b)(4) was initiated for complaint category centrifuge bowl leak/break.Service order (b)(4) was completed: field engineer cleaned up the instrument and performed system checkout procedure.No further action required.The assessment is based on info available at the time of the investigation.The customer sent photos for eval; this eval is still in progress.A supplemental report will be filed when this eval is complete.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MED PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: 440 us rte 22 east ste 140; bridgewater, NJ 08807
• MDR Report Key: 4460588
• MDR Text Key: 20296764
• Report Number: 2523595-2015-00011
• 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: 01/05/2015

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: 10/01/2016
• Device Lot Number: C351-KIT
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2015
• Initial Date FDA Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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: 51 YR
• Patient Weight: 54