MAUDE Adverse Event Report: THERAKOS INC. THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number 6661

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2013

Event Type  malfunction  

Manufacturer Narrative

Batch record review of lot b335 was conducted.There were no non conformances associated with this issue for this lot.Lot met release requirement.Complaint lot review conducted for lot b335 and no add'l complaints for collect pressure dome leak were reported to date for this lot.No trends detected.No product was returned for investigation; therefore, the assessment is based on info available at the time of the investigation.Complaints of this nature are monitored through tracking and tracking.Should a trend arise, further action will be taken.(b)(4).

Event Description

Customer called to report a collect pressure dome leak that occurred during a treatment procedure.Name and function of complainant: same as rptr.Customer called to report pressure dome leak.Customer stated they first got an air detected alarm and noted there was air in the collect line close to pt's access line.Customer flushed pt's access line.However customer noted there was air in the collect line so customer attempted to flush the collect line with a syringe, this is when blood leaked from collect pressure transducer.Treatment was aborted and blood was not returned to the pt.Pt was well and in stable condition.Customer did not return kit for investigation.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey avenue; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east; suite 140; bridgewater, NJ 08807 ; 9083675452
• MDR Report Key: 3703382
• MDR Text Key: 18564051
• Report Number: 2523595-2014-00006
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P680003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/16/2013

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: 09/01/2015
• Device Model Number: 6661
• Device Lot Number: B335 KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2013
• Initial Date FDA Received: 01/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 120