MAUDE Adverse Event Report: THERAKOS, INC. CELLEX

Model Number CELLEX

Device Problem Connection Problem (2900)

Patient Problem No Information (3190)

Event Date 02/06/2015

Event Type  Injury  

Event Description

While setting up the cellex photopheresis device, it was noted the centrifuge bowl did not sit properly in the bowl holder.The grooves at the bottom of the bowl were not in the correct position which caused the centrifuge bowl not to engage in the locked position.

• Brand Name: CELLEX
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC.; bridgewater 08807
• MDR Report Key: 4540811
• MDR Text Key: 5507933
• Report Number: MW5040834
• 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: 02/18/2015

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention