MAUDE Adverse Event Report: THERAKOS THERAKOS CELLEX PHOTOPHERESIS SYSTEMS

Model Number CELLEX

Device Problems False Reading From Device Non-Compliance (1228); Filling Problem (1233); Device Displays Incorrect Message (2591)

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

Event Date 04/16/2014

Event Type  malfunction  

Event Description

Centrifuge bowl optic sensor reading spontaneously fluctuated intra-extracorporeal photopheresis single-needle mode treatment process, from 110-190s (vice versa) leading to imminent red cell pump alarm.Carried out therakos/mfr troubleshoot guidelines at this time that required repurging 2 times; called up therakos tech support for further troubleshoot recommendations due to failure to maintain optic bowl sensor level (150) as required by mfr.Proceeded to early buffy coat stage as whole blood processed reached 1260mls (treated short vs 1500mls wbp goal).No pt complication after photoactivation and reinfusion of buffy coat.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEMS
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS; raritan NJ
• MDR Report Key: 3784042
• MDR Text Key: 4363350
• Report Number: MW5035843
• Device Sequence Number: 1
• Product Code: LNR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/16/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2015
• Device Model Number: CELLEX
• Device Lot Number: B349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 45