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

Lot Number RNP

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Reaction (2414); Loss of consciousness (2418)

Event Date 02/09/2016

Event Type  Injury  

Manufacturer Narrative

This system was used for treatment.No kit lot number provided; therefore, batch record review could not be conducted.The uvadex lot number was not provided.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 category vasovagal reaction.No trend was identified for this issue.The assessment is based on information available at the time of the investigation.There is no device malfunction.Since the vasovagal reaction occurred during treatment and medical intervention of iv fluids and oxygen was needed, this case is reportable as an mdr.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 experienced a vasovagal reaction during a treatment, just before starting photoactivation.Treatment was in single needle mode (snm), with collect and return flow rates reportedly at 70 ml/min.Operator noted the patient was "unresponsive" but breathing, and the crash team was called.Blood pressure was noted to be hypotensive but has responded to intervention.He received iv fluids, 6 l of oxygen per face mask, and got an ecg.Treatment was ended and all patient blood product was returned to the patient.Patient is stable, and will likely be discharged home after a period of further observation and pending physician assessment.On 10feb2016, therakos' clinical services specialist (css) called the customer to obtain further details: the event happened at the end of photoactivation, with 2 minutes remaining.Total photoactivation time was 14 minutes in total.The nurse said it was unlikely due to hypovolemia because most of the blood was already returned and the fluid balance was positive at the time.Patient was kept for observation for about one hour and then discharged; he was doing well at that time.He was referred back to his own hematologist.Customer is not returning any products for investigation.

• 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: 5471825
• MDR Text Key: 39426062
• Report Number: 2523595-2016-00041
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: 10705030100009
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 02/09/2016

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 Lot Number: RNP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2016
• Initial Date FDA Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 23 YR
• Patient Weight: 77