MAUDE Adverse Event Report: MALLINCKRODT PHARMACEUTICALS/ THERAKOS, INC. CELLEX PHOTOPHERESIS PROCEDURAL KIT; CELLEX KIT

Catalog Number CLXUSA

Device Problems Defective Device (2588); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2017

Event Type  Injury  

Event Description

Defective photopheresis kit.Unable to pass prime cycle due to multiple "prime 4" alarms.Two kits were disposed while attempting to prime the device.The kits were from 2 different lot numbers.This event did not reach the patient but resulted in procedure delay.

• Brand Name: CELLEX PHOTOPHERESIS PROCEDURAL KIT
• Type of Device: CELLEX KIT
• Manufacturer (Section D): MALLINCKRODT PHARMACEUTICALS/ THERAKOS, INC.
• MDR Report Key: 6525637
• MDR Text Key: 73955685
• Report Number: MW5069358
• Device Sequence Number: 2
• Product Code: LNR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/22/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2018
• Device Catalogue Number: CLXUSA
• Device Lot Number: E369
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 60 YR
• Patient Weight: 92