MAUDE Adverse Event Report: THERAKOS, INC XTS PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Leak/Splash (1354); Insufficient Flow or Under Infusion (2182); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/27/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction of the tubing leak.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.A batch record review of kit lot e712 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot e712 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories, leak centrifuge alarm and tubing leak.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.(b)(4).

Event Description

The customer's biomed called to report a leak centrifuge alarm and a tubing leak that occurred during a treatment procedure.The biomed stated that the leak originated at the centrifuge bowl's outlet line.The biomed reported that the leak occurred during the first buffy coat collection.The biomed stated that the treatment was aborted with no blood/products returned to the patient.The biomed reported that the patient's provider had ordered a transfusion of two units of packed red blood cells due to the patient's blood loss.On (b)(6) 2017, the biomed stated that the patient's estimated blood loss was around 250 ml based on the amount that was left in the kit's centrifuge bowl and disposable tubing.The biomed reported that only one unit of packed red blood cells was transfused to the patient.The biomed provided the contact information for the customer who ran the treatment.On may 05, 2017, the customer who ran the treatment was contacted.The customer stated that they will not be returning the kit for investigation.The customer confirmed that the patient was in stable condition and did not need any further medical intervention beyond the transfusion of the one unit of packed red blood cells.On may 08, 2017, the customer reported that the patient's pre-procedure hematocrit (hct) test was performed by "pricking" the patient's finger for a drop of blood and this blood was tested via point of care test equipment.The patient's pre-procedure hematocrit level was determined to be 30% based on this testing method.The customer stated that the point of care test equipment was not as accurate as compared to sending the blood down to the lab.The customer reported that they used this form of testing on the first day of consecutive treatment days in order to expedite the initiation of the treatment.The customer stated that after obtaining the hct of 30% via the point of care testing equipment, they started the patient's vascular access device (vad).The customer reported that prior to starting the treatment they performed a blood draw from the patient's vad and sent it to the lab for a complete blood count (cbc).The customer stated that they did not wait for the cbc results prior to starting the treatment.The customer reported that the cbc results arrived after the tubing leak occurred.The customer stated that the patient's hct level based on the cbc results was 26%.The customer reported that the patient was asymptomatic after the leak.The customer stated that the physician had ordered the blood transfusion in order to raise the patient's hct level above 27%, which is the criteria for performing an ecp treatment.The customer confirmed that the blood transfusion was not ordered due to the leak, but was ordered due to the patient's pre-procedure cbc hct level of 26%.The customer reported that the patient was only transfused with one unit of packed red blood cells.The customer stated that shortly after the blood transfusion was completed, they "re-started" the patient's treatment on a new instrument.The customer reported that the patient tolerated this treatment well and with no issues.The customer stated that the patient remained asymptomatic.The customer also reported that the patient returned on (b)(6) 2017 for their second treatment.The customer stated that the patient tolerated this second treatment well and with no issues.The customer reported that the patient's pre-procedure hct level for their second treatment was 29%.The kit was not returned for investigation.

• Brand Name: XTS PHOTOPHERESIS SYSTEM
• Type of Device: XTS PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC; hampton NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; po box 9001; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 6577053
• MDR Text Key: 75664144
• Report Number: 2523595-2017-00097
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200027
• UDI-Public: (01)20705030200027(10)E712(17)210301
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 03/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: XT125
• Device Lot Number: E712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2016
• 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 Age: 60 YR
• Patient Weight: 52