MAUDE Adverse Event Report: MALLINCKRODT PHARMACEUTICALS CELLEX PHOTOPHERESIS (ECP) PROCEDURAL KIT

Lot Number F308

Device Problems Break (1069); Disconnection (1171); Device Inoperable (1663)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

During an extracorporeal photopheresis (ecp) treatment, using the cellex instrument, while purging air, the upper drive tube clip failed, causing the drive tube to disconnect from the clip.This caused the drive tube to become completely severed between the upper and lower drive tube bearings.The kit installation was performed correctly by an experienced rn, and verified by second experienced rn.The patient lost approximately 151 ml of whole blood, and had a post-incident hematocrit of 27.

• Brand Name: CELLEX PHOTOPHERESIS (ECP) PROCEDURAL KIT
• Type of Device: PHOTOPHERESIS
• Manufacturer (Section D): MALLINCKRODT PHARMACEUTICALS
• MDR Report Key: 6659930
• MDR Text Key: 78289868
• Report Number: MW5070560
• Device Sequence Number: 0
• 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: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2019
• Device Lot Number: F308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/20/2017
• 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