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

Lot Number D371-KIT

Device Problem Device Displays Incorrect Message (2591)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot d371 was conducted.There were no nonconformances associated with this lot.The lot met 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 for complaint categories, alarm #18: system pressure and pressure dome membrane leak.No trends were detected for these complaint categories.However, a corrective and preventive action (capa) was initiated for the investigation of pressure dome membrane leak and this capa is now closed.The assessment is based on information available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.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

The customer reported that they received an alarm #18: system pressure alarm at 457 ml of whole blood processed (wbp).The customer stated that after the alarm#18: system pressure alarm occurred, there was a blood leak at the system pressure dome.The customer was advised to disconnect the patient from the kit and to flush the patient's catheter.The customer aborted the treatment with no blood returned to the patient.The customer stated that the patient's blood pressure was 131/80 after the aborted treatment and the patient's hematocrit was 40.4 before treatment.Thus, the patient's physician did not feel a blood transfusion was necessary at this time.The customer reported that the patient was in stable condition.The customer elected not to return the kit for investigation.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC; hampton NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 5605465
• MDR Text Key: 44459284
• Report Number: 2523595-2016-00111
• 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 faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/28/2016

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: 12/01/2017
• Device Lot Number: D371-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2016
• Initial Date FDA Received: 04/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• 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: 60