MAUDE Adverse Event Report: JMS SINGAPORE PTE LTD WINGEATER A.V.FISTULA 15GX1" BE 30CM W/CLAMP; JMS WINGEATER A.V.FISTULA NEEDLE SET

Model Number 820-5002-33

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

Patient Problem Hemolysis (1886)

Event Date 06/19/2019

Event Type  Injury  

Manufacturer Narrative

An area technical operations manager (atom) reported that a hemodialysis patient experienced hemolysis event.Upon follow up, the hemolysis event appears to have occurred between 2019.The patient's pre-hemodialysis treatment labs were drawn on (b)(6) 2019 without any reported issues with the lab specimen.On (b)(6) 2019, the clinic manager reviewed the lab results which were drawn post hemodialysis treatment and noticed the patient had a drop in their baseline hemoglobin from 11 to 9.5.The patient required a blood transfusion; however, they were not admitted to the hospital.The patient was reported dialyzing with a fresenius 2008t hemodialysis machine, fresenius bloodlines, fresenius 180 dialyzers, fresenius granuflo acid (2551) 2.0 potassium/2.5 calcium, fresenius naturalyte 4000 bicarbonate, fresenius clic blood chamber and fresenius normal saline.It was reported there were no visual defects or anything unexpected with any of the fresenius products used, as well as no machine alarms, clotting events and/or dialyzer leaks in relation to the hemolysis event.It was reported there was nothing unusual in any of the hemodialysis treatments.There were no visible signs of hemolysis during any treatment such as, translucent/cherry colored blood, which is typical with hemolysis in hemodialysis or any patient symptoms.The patient completed all their hemodialysis treatments during the timeframe without any adverse effect.Currently, the cause of the hemolysis event is unknown.

Event Description

An area technical operations manager (atom) reported that a hemodialysis patient experienced hemolysis event.Upon follow up, the hemolysis event appears to have occurred between (b)(6) 2019 and (b)(6) 2019.The patient's pre-hemodialysis treatment labs were drawn on (b)(6) 2019 without any reported issues with the lab specimen.On (b)(6) 2019, the clinic manager reviewed the lab results which were drawn post hemodialysis treatment and noticed the patient had a drop in their baseline hemoglobin from 11 to 9.5.The patient required a blood transfusion; however, they were not admitted to the hospital.The patient was reported dialyzing with a fresenius 2008t hemodialysis machine, fresenius bloodlines, fresenius 180 dialyzers, fresenius granuflo acid (2551) 2.0 potassium/2.5 calcium, fresenius naturalyte 4000 bicarbonate, fresenius clic blood chamber and fresenius normal saline.It was reported there were no visual defects or anything unexpected with any of the fresenius products used, as well as no machine alarms, clotting events and/or dialyzer leaks in relation to the hemolysis event.It was reported there was nothing unusual in any of the hemodialysis treatments.There were no visible signs of hemolysis during any treatment such as, translucent/cherry colored blood, which is typical with hemolysis in hemodialysis or any patient symptoms.The patient completed all their hemodialysis treatments during the timeframe without any adverse effect.Currently, the cause of the hemolysis event is unknown.

Event Description

An area technical operations manager (atom) reported that a hemodialysis patient experienced hemolysis event.Upon follow up, the hemolysis event appears to have occurred between (b)(6) 2019.The patient's pre-hemodialysis treatment labs were drawn on (b)(6) 2019 without any reported issues with the lab specimen.On (b)(6) 2019, the clinic manager reviewed the lab results which were drawn post hemodialysis treatment and noticed the patient had a drop in their baseline hemoglobin from 11 to 9.5.The patient required a blood transfusion; however, they were not admitted to the hospital.The patient was reported dialyzing with a fresenius 2008t hemodialysis machine, fresenius bloodlines, fresenius 180 dialyzers, fresenius granuflo acid (2551) 2.0 potassium/2.5 calcium, fresenius naturalyte 4000 bicarbonate, fresenius clic blood chamber and fresenius normal saline.It was reported there were no visual defects or anything unexpected with any of the fresenius products used, as well as no machine alarms, clotting events and/or dialyzer leaks in relation to the hemolysis event.It was reported there was nothing unusual in any of the hemodialysis treatments.There were no visible signs of hemolysis during any treatment such as, translucent/cherry colored blood, which is typical with hemolysis in hemodialysis or any patient symptoms.The patient completed all their hemodialysis treatments during the timeframe without any adverse effect.Currently, the cause of the hemolysis event is unknown.

Manufacturer Narrative

An area technical operations manager (atom) reported that a hemodialysis patient experienced hemolysis event.Upon follow up, the hemolysis event appears to have occurred between 2019.The patient's pre-hemodialysis treatment labs were drawn on (b)(6) 2019 without any reported issues with the lab specimen.On (b)(6) 2019, the clinic manager reviewed the lab results which were drawn post hemodialysis treatment and noticed the patient had a drop in their baseline hemoglobin from 11 to 9.5.The patient required a blood transfusion; however, they were not admitted to the hospital.The patient was reported dialyzing with a fresenius 2008t hemodialysis machine, fresenius bloodlines, fresenius 180 dialyzers, fresenius granuflo acid (2551) 2.0 potassium/2.5 calcium, fresenius naturalyte 4000 bicarbonate, fresenius clic blood chamber and fresenius normal saline.It was reported there were no visual defects or anything unexpected with any of the fresenius products used, as well as no machine alarms, clotting events and/or dialyzer leaks in relation to the hemolysis event.It was reported there was nothing unusual in any of the hemodialysis treatments.There were no visible signs of hemolysis during any treatment such as, translucent/cherry colored blood, which is typical with hemolysis in hemodialysis or any patient symptoms.The patient completed all their hemodialysis treatments during the timeframe without any adverse effect.Currently, the cause of the hemolysis event is unknown.

• Brand Name: WINGEATER A.V.FISTULA 15GX1" BE 30CM W/CLAMP
• Type of Device: JMS WINGEATER A.V.FISTULA NEEDLE SET
• Manufacturer (Section D): JMS SINGAPORE PTE LTD; 440 ang mo kio; industrial park 1; singapore, 56962 0; SN 569620
• MDR Report Key: 9085658
• MDR Text Key: 164068245
• Report Number: 3002807350-2019-00010
• Device Sequence Number: 1
• Product Code: FIE
• UDI-Device Identifier: 08888483005291
• UDI-Public: 08888483005291
• Combination Product (y/n): N
• PMA/PMN Number: K111948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

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 Expiration Date: 11/12/2023
• Device Model Number: 820-5002-33
• Device Lot Number: 181112351
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2019
• Distributor Facility Aware Date: 08/19/2019
• Device Age: 7 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/13/2019
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: 08/22/2019
• Supplement Dates FDA Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 82