MAUDE Adverse Event Report: MALINCKRODT PHARMACEUTICALS CELLEX PHOTOPHERESIS (ECP) PROCEDURE KIT; SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL

Lot Number G375

Device Problems Material Frayed (1262); Explosion (4006)

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

Event Date 02/19/2019

Event Type  Injury  

Event Description

During the priming process prior to an extracorporeal photopheresis (ecp) treatment, the drive tube was severed at the top drive tube clip, appearing to be a ¿clean cut¿.The lower portion of the drive tube appeared frayed, presumably because of the contact it made while spinning freely within the centrifuge chamber after the sever occurred.The metal ring used to seat the drive tube into the clip was noted at the bottom of the force of the severed drive tube while spinning.The patient was present, but had been hooked up to the machine.A similar incident occurred with the same lot number (g375) procedural kit within 2 weeks of this incident (see separate form 3500) where the centrifuge bowl exploded after treatment had begun.

• Brand Name: CELLEX PHOTOPHERESIS (ECP) PROCEDURE KIT
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
• Manufacturer (Section D): MALINCKRODT PHARMACEUTICALS; bedminster NJ 07921
• MDR Report Key: 8405714
• MDR Text Key: 138392947
• Report Number: MW5084786
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Lot Number: G375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2019
• 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