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

Model Number CELLEX

Device Problem Fitting Problem (2183)

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

Event Date 02/03/2016

Event Type  malfunction  

Event Description

Reported by operators, kit malfunction noted during installation.Centrifuge bowl would not lock into centrifuge chamber.Nurse not able to use kit for procedure.New kit retrieved and installed for treatment.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC.; west chester PA
• MDR Report Key: 5515884
• MDR Text Key: 40938037
• Report Number: MW5061032
• 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: 03/09/2016

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 Model Number: CELLEX
• Device Lot Number: D312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 9 YR
• Patient Weight: 29