MAUDE Adverse Event Report: THERAKOS XTS PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

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

Patient Problem Thrombosis (2100)

Event Date 08/09/2018

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to both the patient's hospitalization and the medical intervention of the eliquis 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.There was no specific xts instrument serial number mentioned in the complaint; thus a device history review could not be conducted.Trends were reviewed for complaint category, thrombosis.No trends were detected for this complaint category.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: thrombosis.(b)(4).

Event Description

The distributor emailed to report that a patient experienced a thrombosis following an extracorporeal photopheresis (ecp) treatment procedure.The distributor stated that after the patient successfully completed 41 ecp treatment procedures using solely the xts instrument, the customer on (b)(6) 2018 began alternating the patient's ecp treatments procedures between the xts and cellex instruments that were located at the customer's site.The distributor reported that the patient was being treated twice a week with ecp.The distributor stated that following the patient's ecp treatment with an xts instrument on (b)(6) 2018, the patient developed a thrombosis in their upper left limb.The distributor reported that there had been "a low collection flow alarm" during the treatment but this alarm was resolved with "adjustment".The distributor stated that the treatment was run in single needle mode and the patient's left arm was connected to the instrument at the time of the treatment.The distributor reported that 500ml of citrate with 1ml of heparin was used as the anticoagulant for this treatment at a 10:1 ratio.The distributor stated that the treatment was successfully completed with both blood and uvadex treated cells returned to the patient.However, the distributor reported that after the completed treatment procedure, the patient told her doctor that both her left arm and hand were very swollen.The distributor reported that the following day, (b)(6) 2018, the patient was sent to the hospital for a doppler exam where she was diagnosed with a thrombosis in her left arm.The distributor stated that the patient was then admitted to the hospital.The distributor reported that they did not know what treatments or medications the patient may have been given in the hospital in order to resolve the patient's thrombosis.The distributor stated that the patient was discharged in stable condition from the hospital on (b)(6) 2018.The distributor reported that the patient was discharged with the following medications bactrim f, aciclovir, omeprazol, predinisona 5mg, ursaco, ibrutinibe, eliquis, aldactone, and hidroclorotiazida.The distributor stated that the patient's ecp treatments were still on hold.The distributor reported that the customer stated that the patient did not have any underlying conditions that could have caused or contributed to their left arm thrombosis.The distributor stated that the customer believed that the patient's ecp treatment procedures could have contributed to the patient's reported condition.No product was returned for investigation.

• Brand Name: XTS PHOTOPHERESIS SYSTEM
• Type of Device: XTS 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: 8007713
• MDR Text Key: 125106527
• Report Number: 2523595-2018-00158
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/25/2018

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: Health Professional
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: XTS
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2018
• Initial Date FDA Received: 10/25/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 65