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

Lot Number G314

Device Problems Defective Alarm (1014); Burst Container or Vessel (1074); Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923)

Patient Problem Blood Loss (2597)

Event Date 05/29/2018

Event Type  Injury  

Event Description

During an extracorporeal photopheresis (ecp) treatment during the purging air phase, and after approximately 142 ml of whole blood had been processed, the centrifuge bowl dislodged from the platen, and burst.There were no alarms that occurred prior to this.Procedural kit installation was verified by 2 separate rns who confirmed drive tube clips were closed at the start of the procedure.Blood-spill was significant.The patient lost approximately 150 ml of blood.The instrument was pulled from service, and cleaned and repaired by the manufacturer's contracted service company.

• Brand Name: CELLEX PHOTOPHERESIS (ECP) PROCEDURAL KIT
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
• Manufacturer (Section D): MALLINCKRODT PHARMACEUTICALS; bedminster NJ 07921
• MDR Report Key: 7582229
• MDR Text Key: 110643554
• Report Number: MW5077700
• 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: 06/05/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2020
• Device Lot Number: G314
• Was Device Available for Evaluation?: Yes
• 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: 74 YR