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

Device Problems Failure to Transmit Record (1521); Sensing Intermittently (1558); High Test Results (2457)

Patient Problem Hemolysis (1886)

Event Date 11/03/2016

Event Type  malfunction  

Event Description

The collect pressure sensor on this apheresis device failed to detect and record the pressure.This sensor is intended to monitor for excess negative pressure, i.E.-notify the operator of venous access occlusion.There were air alarms during the procedure, but not collect pressure alarms.Toward the end of the procedure, the plasma in the device was noted to be pink tinged, indicating possible hemolysis.The product collected was tested for plasma free hemoglobin.The result was extremely elevated (>120mg/dl), so the product was not returned to the patient.We believe that collect pressure sensor failure may have allowed excessive negative pressure to be exerted on this patient's central venous catheter, which could have caused hemolysis in this product.Of note - therakos, the company that makes the cellex device, acknowledges that customers around the world have been reporting intermittent failure in the collect pressure sensors.Manufacturer response for photopheresis system kit, (brand not provided) (per site reporter): this issue has gone on for some time.When our facility switched distributors, we again received kits that failed.Manufacturer was made aware of this.According to the user, this problem has been reported across the country.

• Brand Name: CELLEX
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
• Manufacturer (Section D): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• MDR Report Key: 6137697
• MDR Text Key: 61206062
• Report Number: 6137697
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/18/2016,11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2016
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES; NO.