MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Leak/Splash (1354); Device Displays Incorrect Message (2591); Inadequate User Interface (2958)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2016

Event Type  malfunction  

Manufacturer Narrative

System was used for treatment.Kit lot e213 was reviewed.There were no non-conformances.This lot met all release requirements.Trends were reviewed for complaint categories pressure dome membrane leak, alarm #16: collect pressure, alarm #17: return pressure and alarm #45: red blood cell pump alarm and no trend was detected for these categories.This assessment is based on the information available at the time of the investigation.No product was returned by the customer for investigation; therefore, it could not be determined if this specific product met specification.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Investigation completed.(b)(4).Device not returned.

Event Description

Customer reported a leak at the system pressure dome.Previous alarms: alarm #16: collect pressure, alarm #17: return pressure and alarm #45: red blood cell pump alarm.Per the communication between the nurse and the therako's clinical specialist, it seems that the nurse misjudged the situation and made the corrective actions for too low interface, when in fact it was too high.The bowl optic sensor (bos) threshold value was lowered to 120 and the red blood cell (rbc) pump alarm kept posting.Customer then stopped/re-started and then noticed a leak on the pump deck, coming from the system pressure dome.The treatment was aborted.Patient was reported to be in stable condition.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; hampton NJ 08827
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street, suite 30; west chester PA 19380
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 6188728
• MDR Text Key: 63206525
• Report Number: 2523595-2016-00279
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/15/2016

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: 09/01/2018
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: E213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2016
• Initial Date FDA Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• 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: 51 YR
• Patient Weight: 71