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

Lot Number E305 - KIT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Chills (2191); Patient Problem/Medical Problem (2688)

Event Date 04/26/2016

Event Type  Injury  

Manufacturer Narrative

This system was used for treatment.Kit lot e305 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 for all complaint categories and no trends were detected for complaint category cough, weakness, hypotension, chills or "seeing the color purple".Low (narrow) pulse pressure-a pulse pressure is considered abnormally low if it is less than 25% of the systolic value.The most common cause of a low (narrow) pulse pressure is a drop in left ventricular stroke volume.If the pulse pressure is extremely low, i.E.25 mmhg or less, the cause may be low stroke volume, as in congestive heart failure and/or shock.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 patient on cellex instrument 40549 that is not feeling well.Customer reported the male patient started coughing so much that he is out of breath, the patient reported "seeing the color purple", feeling weak, and very cold.Customer stated the patient started coughing when the patient's dialysis catheter was accessed to draw labs prior to starting ecp.Customer has processed 447ml whole blood processed, the patient is alert in the trendelenburg position with his head higher, warm blankets applied, a drink was offered to the patient, in double-needle mode collecting at 30ml/min and returning at 35ml/min (blood pressure: 70/64).Css advised the customer to reduce the return rate to 15ml/min and end the treatment.Customer stated the patient was not coughing as much, catching his breath.Patient stated his vision returned to normal, customer stated his vitals were also returning to normal.Customer stated the patient is an md himself, and she will give the patient some saline before sending the patient home.Patient reported to be stable and alert.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC; hampton NJ 08827
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave; buffalo NY 14211
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 5660610
• MDR Text Key: 45329011
• Report Number: 2523595-2016-00120
• 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: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Expiration Date: 02/01/2018
• Device Lot Number: E305 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2016
• Initial Date FDA Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• 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 Outcome(s): Required Intervention
• Patient Weight: 57