MAUDE Adverse Event Report: THERAKOS, INC. EXPTRACORPOREAL PHOTOPHERSIS INSTRUMENT & KIT; SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL

Model Number CELLEX

Device Problems Volume Accuracy Problem (1675); Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 12/16/2014

Event Type  malfunction  

Event Description

During ecp treatment had cellex alarm #45 -- red cell pump alarm x5 at 310, 377, 447, 563 and 625ml wbp (whole blood processed).Stopped/restarted with each occurrence (stopped to allow red blood cells to settle in centrifuge bowl then re-spin when restarted).Decreased collect/return rates at 20ml/min.The centrifuge bowl volume on the screen did not match the volume in the centrifuge bowl which is an indicator that the wbcs collected thus far could be lost.Lowered wbp at 721ml to initiate early buffy in order to treat the wbcs that were collected thus far.The standard goal amount of wbp is 1460ml - therakos indicates that 500ml or greater wbp provides a sufficient number of wbcs to treat.Therakos notified and recommended instrument service.Biomed serviced machine and adjusted the bowl optic sensor to slightly higher angle.Cellex kit sequestered for biomedical engineering to retrieve and return to therakos for further investigation.

• Brand Name: EXPTRACORPOREAL PHOTOPHERSIS INSTRUMENT & KIT
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
• Manufacturer (Section D): THERAKOS, INC.; 10 north high stret; suite 300; west chester PA 19380
• MDR Report Key: 5415908
• MDR Text Key: 37628812
• Report Number: 5415908
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2015

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: No Information
• Device Model Number: CELLEX
• Device Catalogue Number: 2040
• Device Lot Number: 351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/17/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27 YR