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

Catalog Number CLXUSA

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 08/14/2014

Event Type  malfunction  

Event Description

Incident occurred during priming of cellex instrument and did not involve an actual patient treatment but did result in a delay in starting treatment.Had several prime 4 alarms during prime - unable to resolve and occurred with 3 different kits.Kits sequestered for biomed to retrieve and return to therakos for further investigation and kit credit.Reprimed using a new kit with a different lot number - c308 but unable to use due to the load sensor on instrument not registering the return and treatment bags.Therakos and biomed-instrument needs to be serviced by biomed.Primed a different instrument, with kit lot number c308/368.No alarms occurred during prime and able to initiate treatment; had several air flow alarms during return of the treated wbcs with successful treatment.Therakos and biomed notified; instrument to be serviced by biomed.

• Brand Name: CELLEX KIT
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL, KIT
• Manufacturer (Section D): THERAKOS, INC.; 10 north high street, suite 300; west chester PA 19380
• MDR Report Key: 5048820
• MDR Text Key: 24778789
• Report Number: 5048820
• 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
• Report Date: 06/25/2015,08/06/2015

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 Catalogue Number: CLXUSA
• Device Lot Number: C325/692, C325/592 & C122/168
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/25/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1