MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS (ECP) KIT; EXTRACORPOREAL PHOTOPHERESIS

Lot Number D373

Device Problems Device Alarm System (1012); Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 04/20/2016

Event Type  Injury  

Event Description

During an ecp procedure, the rn noted an audible plastic cracking sound, followed immediately by a "centrifuge leak" alarm.The procedure was stopped, and the rn noted that the centrifuge chamber was sprayed with blood.The patient's access line was immediately clamped, and disconnected from the machine.Further investigation revealed a crack at the bottom of the centrifuge bowl.The procedure was aborted.Approximate patient blood loss was -200ml.

• Brand Name: CELLEX PHOTOPHERESIS (ECP) KIT
• Type of Device: EXTRACORPOREAL PHOTOPHERESIS
• Manufacturer (Section D): THERAKOS; west chester PA 19380
• MDR Report Key: 5641276
• MDR Text Key: 44791027
• Report Number: MW5062161
• Device Sequence Number: 1
• 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: 05/05/2016

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: 12/01/2017
• Device Lot Number: D373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR