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

Catalog Number 2040

Device Problems Incorrect Measurement (1383); Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 09/27/2013

Event Type  malfunction  

Event Description

Began scheduled ecp treatment using cellex & disposable kit lot # b325/647 & acda (anticoagulant) as ordered.Began getting #45 red cell pump alarms @ whole blood processed (wbp) 519ml, 641ml, 717ml.Stopped/restarted bowl after 1st and 2nd alarms and decreased collect rate from 30ml/min to 20ml/min.Contacted therakos tech support engineer, to report alarms and confirmed trouble-shooting.Noted rbc interface continued to rise above level of optic sensor and sensor reading kept dropping to 8-13 (indicating that interface was too high in bowl).Unable to maintain interface in proper position.Decreased wbp target from 1500ml to that collected (717ml) to avoid loss of buffy collection to return bag.Cells collected were treated and patient tolerated procedure without any difficulty.Patient had abnormal rbc morphology.This instrument was serviced approximately two months prior to event by biomed d/t other incidents of red cell alarms.Concern is that there may be kit or instrument issues versus abnormal rbc morphology affecting function of rbc pump.

• Brand Name: CELLEX DISPOSABLE KIT
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
• Manufacturer (Section D): THERAKOS; 440 route 22 east, suite 140; bridgewater NJ 08807
• MDR Report Key: 3700061
• MDR Text Key: 4234553
• Report Number: 3700061
• 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: 03/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 2040
• Device Lot Number: B325/647
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/20/2014
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2014
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 65