MAUDE Adverse Event Report: THERAKOS, INC. CELLEX INSTRUMENT AND KIT; SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL

Model Number CELLEX

Device Problems Device Alarm System (1012); Leak/Splash (1354); Visual Prompts will not Clear (2281)

Patient Problems Fatigue (1849); Hyperglycemia (1905); Weakness (2145); Blood Loss (2597)

Event Date 10/07/2014

Event Type  malfunction  

Event Description

Ecp initiated with air noted in filter at 644ml of whole blood platelets (wbp); no identifiable source evident, had no alarms during prime or during treatment.Two 100ml saline boluses into receptacle, unable to clear air from filter or line, treatment aborted.Vitals=119/65, 71, 97.7f, 16 and patient without complaints.Estimated blood loss=393ml, hct=35.7, plts=295, doctor notified.Kit sequestered, therakos notified and biomedical engineering contacted to service instrument with leak found in pinch valves of red cell pump.Kit to be retrieved by biomed and returned to therakos for further investigation.Re-initiated treatment using a different kit and instrument, with successful treatment.Pre-vitals=169/79, 72, 97.5f, 16 and post-vitals=147/74, 68, 98.1f,16.Patient was instructed to report if develops increased fatigue and weakness.This resulted in: a longer treatment time for the patient; extra nursing time and follow up and caused back up of next patient's scheduled appointment.

• Brand Name: CELLEX INSTRUMENT AND KIT
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
• Manufacturer (Section D): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• MDR Report Key: 5415956
• MDR Text Key: 37634830
• Report Number: 5415956
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CELLEX
• Device Catalogue Number: 2040
• Device Lot Number: C337/324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/16/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1