MAUDE Adverse Event Report: THERAKOS, INC. CELLEX DISPOSABLE KIT; SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL

Model Number CELLEX

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 01/08/2014

Event Type  malfunction  

Event Description

During an ecp procedure had four #45 - red blood cell pump alarms that occurred at 1295ml, 1333ml, 1349ml and 1364ml of whole blood processed (wbp).The amount of wbp is + or - 1460ml.Lowered wbp to 1364ml to initiate early buffy collection resulting in a partial treatment.Therakos notified and did not want the kit returned.

• Brand Name: CELLEX DISPOSABLE KIT
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
• Manufacturer (Section D): THERAKOS, INC.; 440 route 22 east, suite 140; bridgewater NJ 08807
• MDR Report Key: 3687376
• MDR Text Key: 4238480
• Report Number: 3687376
• Device Sequence Number: 1
• Product Code: LNR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: CELLEX
• Device Catalogue Number: 2040
• Device Lot Number: B346 / 418
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/11/2014
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/11/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMMUNOTHERAPY; NOT APPLICABLE.
• Patient Age: 60 YR
• Patient Weight: 98