MAUDE Adverse Event Report: THERAKOS / MALLINCKRODT HOSPITAL PRODUCTS INC. THERAKOS CELEX PHOTOPHERESIS SYSTEM; SYSTEM, PHOTOPHERESIS, EXTRACOPORATION

Device Problem Output Problem (3005)

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

Event Date 06/18/2019

Event Type  malfunction  

Event Description

The therakos celex photopheresis system failed to collect a buffy coat to be treated.The mfr was contacted to troubleshoot but no solution was found.The pt's blood was returned without loss or adverse event.The smart cart from the procedure was returned to mallinckrodt for analysis but no root cause was determined by them.Fda safety report id# (b)(4).

• Brand Name: THERAKOS CELEX PHOTOPHERESIS SYSTEM
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACOPORATION
• Manufacturer (Section D): THERAKOS / MALLINCKRODT HOSPITAL PRODUCTS INC.
• MDR Report Key: 8831144
• MDR Text Key: 152552124
• Report Number: MW5088393
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/23/2019

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/25/2019
• 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 Age: 52 YR
• Patient Weight: 78