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

Lot Number D306 - KIT

Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

Patient Problems Blood Loss (2597); Test Result (2695)

Event Date 05/06/2015

Event Type  malfunction  

Event Description

Customer called to report a blood leak from the y connection of the patient tubing of the procedural kit.Customer explained that at 1099ml whole blood processed while returning, the customer noticed the pressure readings for the collect and return to be approximately 553mm hg and that is when she noticed the blood leak from the tubing.Customer stated no alarms occurred at any time during the patient treatment.Customer explained the pressure readings were stable and as expected up until this point.Customer stated that the treatment was aborted and a peripheral cbc was drawn, the customer is still waiting for the results before determining if any further medical intervention needs to be performed.Customer stated that when they were disconnecting the patient there was a clot seen in the patient tubing that was connected to the patient collect tubing of the procedural kit.The customer was using acd-a set at 8:1 a/c ratio for a platelet count of 224,000.Customer explained the patient was given one unit (planned) of rbc's before starting her ecp treatment that day.Prior to starting ecp, the patient's hematocrit was 29.9%.Service was dispatched (b)(4).The clinical support specialist called back to follow up, the cbc results were back and were slightly higher than the pre-treatment results, there was no medical intervention given as a result of the blood leak.The customer stated that the patient's port was clotted and there is a team working on the patient's port so that the second treatment could be performed the next day, (b)(6) 2015.Customer also explained that when she went to remove the kit from the instrument, she noticed blood "pooling" in the pressure domes and when she pressed release kit, blood was drawn into the anticoagulant bag and not the saline bag as expected.Customer also stated the anticoagulant pump was not "turning properly".The customer returned the kit for investigation.

Manufacturer Narrative

The system was used for treatment.A review of kit lot d306 was performed and there were no nonconformances related to this complaint.This lot met release requirements.The uvadex lot number was not provided.However, a review of all uvadex lots manufactured since january 2013 was performed.No trends or noncoformances related to the complaint were noted.Trends were reviewed for complaint category, tubing leak.No trends were detected.No corrective and preventive action was executed for this type of event.(b)(4) was completed: the service technician found inaccurate readings on both the collect and the return pressure transducers.He ran a calibration using the pressure sensor test kit and found them to be working and within range.System checkout was completed successfully.This assessment is based on the information available at the time of the investigation.The kit and smartcard data were returned for analysis.A supplemental report will be filed when this analysis is complete.(b)(4).

Manufacturer Narrative

The kit and smartcard data were returned for analysis.Based on the review of the smart card data, the prime was completed successfully and collection started.No alarms, warnings or system errors were recorded.A 1099ml of whole blood was processed and the treatment was aborted.The ac, collect, and return lines were pressure tested for leaks.A leak was confirmed at the 'y' connector and the bubbles that appeared indicated a failed seal between the tubing and the port.The lack of solvent apparent on the tubing bond indicates the likely root cause was manufacturing operator error.As part of the corrective action at the manufacturer, manufacturing operators were retrained on the solvent bonding process.Complaints are monitored through tracking and trending.Should a trend arise, further action will be taken.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS INC.; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave.; buffalo NY 14211
• Manufacturer Contact: dianna inguanzo ; 10 north high street; suite 300; west chester, PA 19380
• MDR Report Key: 4805024
• MDR Text Key: 5829533
• Report Number: 2523595-2015-00144
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860003
• 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,Followup
• Report Date: 05/06/2015

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 Expiration Date: 02/01/2017
• Device Lot Number: D306 - KIT
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2015
• Initial Date FDA Received: 05/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• 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 Weight: 74