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

Lot Number E314

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 06/10/2016

Event Type  Injury  

Event Description

During the purging air sequence during an ecp procedure, the centrifuge bowel shattered inside the centrifuge chamber.The procedure was paused, and the rn inspected the centrifuge chamber.The upper portion of the bowel was shatter, and lying in pieces at the base of the centrifuge chamber.The base of the bowel was still firmly secured in its place.The drive tube separated and its bearings broke from the bowl and seemed to have acted as shrapnel.The clips on the centrifuge did not fall, but the bottom clip was damaged.The approximate blood loss was 194 ml.The manufacturer ((b)(4)) was notified on 06/10/2016, and serviced the machine appropriately on 06/17/2016.

• Brand Name: CELLEX PHOTOPHERESIS (ECP) KIT
• Type of Device: CELLEX PHOTOPHERESIS (ECP) KIT
• Manufacturer (Section D): THERAKOS; west chester PA 19380
• MDR Report Key: 5764638
• MDR Text Key: 48755575
• Report Number: MW5063190
• 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: 06/28/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2018
• Device Lot Number: E314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR