MAUDE Adverse Event Report: THERAKOS XTS PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Leak/Splash (1354); Device Displays Incorrect Message (2591)

Patient Problems Fatigue (1849); No Information (3190)

Event Date 11/29/2017

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 blood transfusion that was given to the patient.Since this event is associated with the kit malfunction, this mdr will only be against the kit.A batch record review of kit lot f701 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot f701 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories, leak centrifuge alarm, tubing leak, fatigue, and low hemoglobin.No trends were detected for these complaint categories.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.Adverse event terms: fatigue and other: low hemoglobin (b)(4).

Event Description

The customer called to report a leak centrifuge alarm and a tubing leak that occurred during a treatment procedure.The customer stated that the leak centrifuge alarm occurred in cycle two of six during the buffy coat collection phase of the treatment procedure.The customer reported that at this point, they realized that there was a small leak (1 to 2 ml) at the neck of the centrifuge bowl.The customer stated that the leak originated at the joint where the fluid logic module's tubing is attached to the centrifuge bowl.The customer reported that they cleaned the leak, however the alarm continued.The customer stated that the treatment was then aborted with no return of blood/products to the patient.The customer reported that the patient was in stable condition and would be able to tolerate the blood loss.The customer stated that they were planning on administering a 200ml fluid bolus to the patient as a preventative measure, prior to starting the patient on another treatment procedure that same day.During a follow-up call with the customer later that in the day, the customer reported that the patient was still in stable condition and had completed the second treatment procedure.The customer stated that the patient would have a follow-up cbc lab drawn on (b)(6) 2017, prior to their next scheduled treatment procedure.The customer reported that the cbc results would determine if the patient would require a blood transfusion.In a follow up call with the customer on (b)(6) 2017, the customer stated that the patient had successfully completed the second treatment procedure on (b)(6) 2017 and that the patient remained asymptomatic.The customer reported that the patient was discharged home in stable condition that day.The customer stated that the patient's (b)(6) 2017 cbc results yielded a hemoglobin of 8 and hematocrit of 24 percent.The customer reported that due to the patient's hemoglobin cbc results, they transfused the patient with two units of blood in order to help the patient compensate for yesterday's loss.The customer stated that the patient's vital signs and clinical condition have remained stable.The customer reported that the patient's only complaint was that she felt "tired" today.The customer stated that they would not be returning the kit for investigation.The kit was not returned for investigation.This medwatch is for the adverse events, fatigue and low hemoglobin.The reportable malfunction of the tubing leak, was submitted under medwatch 2523595-2017-00241.

• Brand Name: XTS PHOTOPHERESIS SYSTEM
• Type of Device: XTS PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 7145200
• MDR Text Key: 95722536
• Report Number: 2523595-2017-00242
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200027
• UDI-Public: (01)20705030200027(10)F701(17)220101
• 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: 12/23/2017

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: 01/01/2022
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: XT125
• Device Lot Number: F701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2017
• 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 Age: 66 YR
• Patient Weight: 38