MAUDE Adverse Event Report: MALLINCKRODT PHARMACEUTICALS THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURE KIT; SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL

Lot Number H334/637

Device Problem Gas/Air Leak (2946)

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

Event Date 10/29/2019

Event Type  malfunction  

Event Description

Twenty six mins after starting photopheresis treatment, the treatment had to be aborted.Air was in the kit (tubing) setting of the air detector alarm and blood was being routed to the treatment bag at an inappropriate time in the treatment.The mallinckrodt expert rep was contacted and stated the treatment should be aborted, due to risk of infection associated with possible breach in system.Fda safety report id# (b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURE KIT
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
• Manufacturer (Section D): MALLINCKRODT PHARMACEUTICALS
• MDR Report Key: 9295350
• MDR Text Key: 165982094
• Report Number: MW5090955
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/06/2019

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
• Device Expiration Date: 05/01/2021
• Device Lot Number: H334/637
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR