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

Lot Number E344

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 11/01/2016

Event Type  Injury  

Event Description

During an extracorporeal photopheresis (ecp) treatment using the cellex instrument, after the saline prime, during purging air, the instrument alarmed, and the bowel shattered inside the centrifuge chamber.The centrifuge did not automatically shut off, and only came to a complete stop after the rn pressed the power button to completely power down the machine.The procedure was aborted, and the patient lost approximately 163 ml of whole blood.Two very sharp pieces of plastic from the shattered bowl were ejected from inside the centrifuge chamber while the centrifuge door was closed and locked in place.This creates an added risk to both the patient and the operator.The kit was installed appropriately, and the installation was verified by a second rn.

• Brand Name: CELLEX PHOTOPHERESIS (ECP) PROCEDURAL KIT
• Type of Device: CELLEX PHOTOPHERESIS (ECP) PROCEDURAL KIT
• Manufacturer (Section D): THERAKOS; west chester PA 19380
• MDR Report Key: 6089450
• MDR Text Key: 59582112
• Report Number: MW5065911
• 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: 11/07/2016

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: 08/01/2016
• Device Lot Number: E344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR