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

Model Number CELLEX

Device Problem Failure to Prime (1492)

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

Event Date 08/15/2014

Event Type  malfunction  

Event Description

Several alarms occurred during priming of cellex instrument - #22 collect test failure alarm x3, unable to resolve.Therakos notified.Biomed was in the process of servicing instrument with a different serial number.Once this was complete, was able to prime this instrument using new kit with successful treatment.Biomed then serviced instrument with serial number that alarmed during priming.This situation occurred prior to contact with the patient and resulted in a 1.8 hour delay in initiating treatment.Patient provided with meal passes for the inconvenience.

Event Description

Several alarms occurred during priming of cellex instrument - #22 collect test failure alarm x3, unable to resolve.Therakos notified.Biomed was in the process of servicing instrument with a different serial number.Once this was complete, was able to prime this instrument using new kit with successful treatment.Biomed then serviced instrument with serial number that alarmed during priming.This situation occurred prior to contact with the patient and resulted in a 1.8 hour delay in initiating treatment.(b)(6).

• Brand Name: CELLEX
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
• Manufacturer (Section D): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• MDR Report Key: 5017544
• MDR Text Key: 23534233
• Report Number: 5017544
• 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
• Report Date: 06/25/2015,07/16/2015

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/25/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR