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

Model Number CELLEX

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/18/2016

Event Type  malfunction  

Event Description

Multiple air alarms with no identifiable cause, peripheral iv (piv) connection secure, line flushed with saline without resistance, good blood return, no complaints of pain/burning.Then had two red cell pump alarms at 304 and 370 wbp followed by two system pressure alarms.Removed centrifuge bowl for further inspection.Several large clumps of coagulated blood noted in centrifuge bowl.Aborted treatment and did a manual return of blood from return bag.There was 378 ml of fluid outside of body to include iv fluids and blood.Treatment restarted per patient request, using a new kit with no alarms or coagulation noted.Successful treatment completed.Therakos notified and kit sequestered.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
• Manufacturer (Section D): THERAKOS, INC.; 10 north high street suite 300; west chester PA 19380
• MDR Report Key: 6088947
• MDR Text Key: 59470104
• Report Number: 6088947
• 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: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CELLEX
• Device Catalogue Number: 2040
• Device Lot Number: D363 / 136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/06/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR