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

Catalog Number CLXUSA

Device Problems Failure to Prime (1492); Device Displays Incorrect Message (2591); Failure of Device to Self-Test (2937)

Patient Problem No Patient Involvement (2645)

Event Date 05/21/2017

Event Type  Injury  

Event Description

Defective photopheresis kit.Unable to pass prime cycle due to multiple "prime 4" alarms.Two kits were disposed when 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 PROCEDUREAL KIT
• Type of Device: CELLEX KIT
• Manufacturer (Section D): MALLINCKRODT PHARMACEUTICALS/ THERAKOS, INC.
• MDR Report Key: 6525679
• MDR Text Key: 73959377
• Report Number: MW5069361
• 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: 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

• 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: E365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2017
• 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
• Treatment: CELLEX PHOTOPHERESIS SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 97