MAUDE Adverse Event Report: THERAKOS THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number CELLEX

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 03/03/2017

Event Type  Injury  

Event Description

Therakos cellex disposable photopheresis kit malfunctioned during patient treatment.Frequent red cell pump alarms.Repurge troubleshooting mechanisms x 3 attempts failed to resolve red cell pump alarms.Early buffy coat phase initiated due to continuous red cell pump alarm.Patient tolerated procedure.Completed session after early buffy coat entered.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS; west chester PA
• MDR Report Key: 6438829
• MDR Text Key: 71152844
• Report Number: MW5068680
• 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: 03/16/2017

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: 09/01/2018
• Device Model Number: CELLEX
• Device Lot Number: E353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR
• Patient Weight: 48