MAUDE Adverse Event Report: THERAKOS THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number CELLEX

Device Problems False Reading From Device Non-Compliance (1228); Filling Problem (1233)

Patient Problem No Code Available (3191)

Event Date 04/17/2014

Event Type  malfunction  

Event Description

Extracorporeal photopheresis treatment procedure was aborted using therakos cellex device due to optic bowl sensor reading's failure to maintain at 150 threshold level as required by mfr.The cellex circuit was repurged 2 times (pt on blood prime) without success.Therakos was contacted by phone; both mfr and ecp rn went through further troubleshooting measures without success.Transfusion md at pt's bedside and ordered to abort treatment procedure.Remaining prbc blood prime was returned to blood bank.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS; raritan NJ
• MDR Report Key: 3784055
• MDR Text Key: 19968597
• Report Number: MW5035844
• Device Sequence Number: 1
• Product Code: LNR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/17/2014

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: Health Professional
• Device Expiration Date: 02/01/2016
• Device Model Number: CELLEX
• Device Lot Number: C309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Weight: 21