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

Lot Number G314

Device Problems Break (1069); Burst Container or Vessel (1074); Device Dislodged or Dislocated (2923)

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

Event Date 05/31/2018

Event Type  Injury  

Event Description

At the end of the purging air sequence during an extracorporeal photopheresis (ecp) treatment, the bowl dislodged from the centrifuge platen and shattered on impact with the centrifuge chamber walls.The procedure was immediately aborted with 152 ml of blood loss to the patient.Despite the centrifuge chamber door being closed and locked, blood splatter from the bowel shattering reached the ceiling, nearby equipment (computer, iv pump, vs monitor), supply cart, curtains at the far end of the bay and the walls.The instrument was pulled from service and will be cleaned and repaired by the manufacturer's contracted service company.This was the second shattered bowl incident in 3 days, using the same lot number of procedural kit.This lot was removed from inventory, and the manufacturer was notified.

• Brand Name: CELLEX PHOTOPHERESIS (ECP) PROCEDURAL KIT
• Type of Device: SYSTEM, PHOTOPHERESIS
• Manufacturer (Section D): MALLINCKRODT PHARMACEUTICALS; bedminster NJ 07921
• MDR Report Key: 7582178
• MDR Text Key: 110647345
• Report Number: MW5077695
• Device Sequence Number: 2
• 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
• Type of Report: Initial
• Report Date: 06/05/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2020
• Device Lot Number: G314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/07/2018
• 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 Age: 24 YR