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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THERAKOS, INC. CELLEX; SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
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THERAKOS, INC. CELLEX; SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL Back to Search Results
Model Number CELLEX
Device Problem False Alarm (1013)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/16/2016
Event Type  malfunction  
Event Description
The therakos cellex photopheresis unit was giving false "air in line" error messages during the priming phase (pre-use) of treatment.After much troubleshooting, it was determined that rf interference from a t-mobile antenna was the source of rf that was creating the false error message to appear.This antenna is located across the street, approx.50 feet away from the patient room where treatment was to be done.It has yet to be determined if the problem is caused by an overly strong signal being sent out by the antenna or if the cellex unit is overly sensitive to inadvertent rf.Manufacturer response for photopheresis unit, cellex (per site reporter): the vendor brought out another cellex.It too was giving false "air in line" error messages.They were very helpful in troubleshooting the problem.(b)(6) called therakos to discuss this.
 
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Brand Name
CELLEX
Type of Device
SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
Manufacturer (Section D)
THERAKOS, INC.
10 north high street
suite 300
west chester PA 19380
MDR Report Key6137756
MDR Text Key61205677
Report Number6137756
Device Sequence Number1
Product Code LNR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 11/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Model NumberCELLEX
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/19/2016
Device Age3 YR
Event Location Hospital
Date Report to Manufacturer11/19/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/01/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO OTHER THERAPIES; NO.
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