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

Lot Number C317/71

Device Problem False Alarm (1013)

Patient Problem No Code Available (3191)

Event Date 06/27/2014

Event Type  malfunction  

Event Description

Multiple return pressure alarms that were not related to patient access.Kit problem.Kit sent back to therakos for investigation and credit.Patient's blood returned to her and treatment ended.Patient declined having another treatment started because of the time.

• Brand Name: CELLEX KIT
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
• Manufacturer (Section D): THERAKOS, INC.; 1001 us route 202; raritan NJ 08869 060
• MDR Report Key: 4251816
• MDR Text Key: 17995858
• Report Number: 4251816
• 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: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Lot Number: C317/71
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2014
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2014
• Patient Sequence Number: 1
• Treatment: OTHER
• Patient Age: 72 YR
• Patient Weight: 98