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

Lot Number D336 - KIT

Device Problems Leak/Splash (1354); Loss of Power (1475); Device Displays Incorrect Message (2591)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/09/2016

Event Type  malfunction  

Manufacturer Narrative

This system was used for treatment.Kit lot d336 was reviewed.There were no non-conformances.This lot met all release requirements.The uvadex lot number was not provided as it was not administered.However, a review of all uvadex lots manufactured since january 2013 was performed.No trends or nonconformances related to the complaint were noted.Trends were reviewed and no trends were detected for complaint category pressure dome membrane leak, no power or system error.However, a corrective and preventive action was initiated for pressure dome membrane leak.Service order feedback was still pending at the time of this report.A supplemental will be created once the service order feedback is received.This assessment is based on 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 through the capa/continuous improvement process.(b)(4).

Event Description

Customer called to report a blood leak at the system pressure dome transducer at 1360 ml whole blood processed, following a power outage.Customer said the power outage extended to the entire clinic.Customer said the cellex displayed a "communications error alarm." customer said when the power turned back on, they noticed that there was blood leaking from the system pressure transducer dome.Customer said she was unable to confirm the source of the leak, but did mention the membrane of the transducer dome was intact.Customer said she thought the system pressure transducer dome of the kit had "popped off" the pressure transducer component on the instrument, but could not be completely certain.Customer said she was able to clean up most of the blood, but is requesting instrument service to check out the instrument and complete the cleaning.Clinical services educator (cse) informed customer a service evaluation would be sent to therakos technical service.Customer requested and received assistance with calculating estimated blood loss.Patient was reported to be stable and did not need any fluids or a blood transfusion.No product was returned for investigation.

Manufacturer Narrative

Service order (b)(4) feedback received: service engineer cleaned instrument, adjusted pump heads and performed system checkout procedure successfully.The investigation conclusion and codes, included in initial report, are not affected by this additional information regarding the service order feedback.(b)(4).Device not returned.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC; 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: 5563104
• MDR Text Key: 43014113
• Report Number: 2523595-2016-00087
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: 10705030100009
• 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 faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/09/2016

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: 06/01/2017
• Device Lot Number: D336 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2016
• Initial Date FDA Received: 04/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• 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 Age: 65 YR
• Patient Weight: 61