MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Visual Disturbances (2140); Malaise (2359); Pallor (2468)

Event Date 01/04/2017

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the medical intervention of the saline that was provided to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.From the instrument perspective, there was no known instrument malfunction and no instrument issue was alleged by the customer.No service was requested by the customer for this adverse event.The instrument's serial number was not provided, thus a device history review could not be performed.Trends were reviewed for complaint categories, malaise, light flashes, other adverse event: paleness, and hypotension.No trends were detected for these complaint categories.The assessment is based on information available at the time of the investigation.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Adverse event terms: malaise, pallor, visual disturbances, and hypotension.(b)(4).S.K.: (b)(6) 2018.

Event Description

The customer reported that a patient experienced malaise, paleness, hypotension and saw light flashes during an extracorporeal photopheresis (ecp) treatment procedure.The customer stated that after 500ml of whole blood processed the patient began to experience malaise.The customer reported that the patient was also pale and complained of seeing light flashes.The customer stated that they decreased the collect rate and administered a saline bolus to the patient.The customer reported that they measured the patient's blood pressure after the administration of the saline bolus and the patient's blood pressure was 98/56mmhg the customer stated the patient's pre procedure blood pressure was 120/73mmhg.The customer stated that the patient recovered after the saline bolus and they were able to successfully complete the treatment procedure with 1576ml of whole blood processed.The customer reported that all of the treated cells were reinfused back to the patient.The customer stated that the patient was in stable condition and was not impacted by the incident.The customer reported that no hospitalization or transfusion was required for the patient.The customer stated that the patient still continues with their ecp treatments with the patient's latest treatment occurring on (b)(6) 2018.No product was returned for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• Manufacturer (Section G): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; college business & tech park; cruiserath road; blanchardstown, dublin D15 T X2V; EI D15 TX2V
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 7627665
• MDR Text Key: 111986961
• Report Number: 2523595-2018-00112
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CELLEX
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 68