MAUDE Adverse Event Report: THERAKOS, INC. THERAKOS XTS PHOTOPHERESIS SYSTEM

Lot Number C742-KIT

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Headache (1880); Nausea (1970); Pain (1994)

Event Date 12/04/2014

Event Type  Injury  

Event Description

The customer called to report multiple blood pump alarms while emptying the bowl in the sixth cycle of the treatment.The customer explained that they had flushed the pt's access and performed a couple of saline boli through the kit without resolution of the blood pump alarms.The customer stated no kinking or clotting in the procedural kit was visible.The pt had a platelet count of 287,000 using 10,000 units of heparin in a 500ml bag of normal saline set at 8:1 ratio for the a/c ratio.The pt's access was patent and without any resistance.The clinical services specialist (css) advised the customer to perform another saline boli to waste, unless the pt could tolerate extra fluid.The customer performed several saline boli to waste and the blood pump alarm did not resolve.Several empty saline alarms occurred during these saline boli.The css advised the customer to strip the tubing towards the saline bag and the alarm cleared.However, the customer was not able to clear the blood pump alarms and decided to perform a manual return.The css directed the customer through the manual return process.The customer was able to drain the centrifuge bowl, but was unable to drain the volume from the flm.The customer explained that there may have been a clot within the flm that was preventing the fluid from exiting the flm and into the recirculation bag.The customer decided to return the fluid in the recirculation bag to the pt using an administration set with a blood filter.The customer, on 12/17/2014, reported that the pt went to the er on the night of (b)(6) 2014 with a hematocrit of 20% and a hemoglobin of 6.5 g/dl.The pt was transfused that night at the hosp where the pt had a transfusion reaction during the transfusion.The pt stayed over night and was discharged from the hosp on (b)(6) 2014.The customer stated that they manually returned all the blood/products from only the residual bag to the pt.The pt was discharged and asymptomatic after treatment procedure.The customer stated that the pt did not have any complaints and was stable when she left.The customer was called again on (b)(6) 2014 in order to verify if there was any clotting seen in any part of the kit.The customer stated that she did not recall seeing any clotting in any part of the kit even after removing the kit from the instrument.An update on 12/22/2014, states that the customer reported an empty saline alarm during the troubleshooting process for the blood pump error alarms.The css advised the customer to strip the saline tubing towards the saline bag in order to resolve the empty saline alarm, this action did resolve the empty saline alarm.The customer will return the used procedural kit for further investigation.No service order was generated.

Manufacturer Narrative

A batch record review of lot c742 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.Trends were reviewed for complaint categories, blood pump error alarm, empty saline alarm, and anemia.No trends were detected for either of these complaint categories.No capa's were initiated for complaint categories, empty saline alarm nad anemia.Blood pump error alarm was investigated through capa (b)(4).Capa (b)(4) was closed.This assessment is based on info available at the time of the investigation.The customer has agreed to return the kit for eval; however, at this time the mfr had yet to receive the kit.Once the kit has been received by the mfr, analysis of the returned kit will begin.A supplemental report will be filed when this analysis is complete.(b)(4).

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east; ste 140; bridgewater, NJ 08807
• MDR Report Key: 4380311
• MDR Text Key: 15969051
• Report Number: 2523595-2014-00344
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P680003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/04/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2019
• Device Lot Number: C742-KIT
• Other Device ID Number: 10705030100016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2014
• Initial Date FDA Received: 12/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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: 69 YR
• Patient Weight: 80