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

Lot Number G375

Device Problems Break (1069); Fluid/Blood Leak (1250); Failure to Shut Off (2939)

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

Event Date 03/05/2019

Event Type  Injury  

Event Description

During an extracorporeal photopheresis (ecp) treatment, after approximately 227 ml blood had been processed, the centrifuge bowl shattered inside the centrifuge chamber.The base of the centrifuge bowl remained seated in the base with a piece of the side of the bowl still attached.Blood leaked from the centrifuge chamber onto the pump deck while the door was still closed and latched.The machine failed to automatically turn off after the bowl shattered and had to be manually turned off by the rn operating the instrument.The line to the patient was immediately clamped, and the procedure aborted.Treatment was not re-administered due to the patient¿s condition.The instrument was pulled from service, and cleaned and repaired by the manufacturer¿s contracted service company the following day.

• Brand Name: CELEX PHOTOPHERESIS (ECP) PROCEDUAL KIT
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
• Manufacturer (Section D): MALINCKRODT PHARMACEUTICALS; bedminster NJ 07921
• MDR Report Key: 8405727
• MDR Text Key: 138401924
• Report Number: MW5084787
• 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
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Lot Number: G375
• Was Device Available for Evaluation?: No
• 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