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

Our manufacturing process was within control and no abnormality was found on the given product lot.The product lot met all the qa outgoing inspection criteria prior releasing to the market.Based on the results of reserved samples evaluation and dhr analysis, there was no abnormality found on complaint lot.Investigation was carried out for reported lot 181112351.Based on the results of dhr analysis and reserve samples evaluation, there was no abnormality found on the reported product lot.We would like to emphasize that our manufacturing process was within control and all our products met the jms qa outgoing inspection criteria prior to market release.There was no information provided by reporter that there was any known abnormalities caused by our product.Nonetheless, briefing was conducted on (b)(6) 2019 to all related operators and inspectors for their awareness on the reported defect.Lastly, jms will continue to maintain good quality of our products and ensure that only good quality products will be delivered to customers.We will continue to work with our customers to improve our products quality.

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 06/19/2019, 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 8.9 to 7.2.The patient was admitted into the hospital due to weakness on (b)(6) 2019 with a hemoglobin of 5.9 and positive schistocytes.The patient required a blood transfusion.The patient was discharged on (b)(6) 2019.Further details regarding the patient's hospitalization are currently unknown.Reportedly, the patient continues to receive hemodialysis treatments.The patient was reported dialyzing with a fresenius 2008t hemodialysis machine, fresenius bloodlines, fresenius 160 and 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
• Manufacturer (Section G): PT. JMS BATAM CAMMO INDUSTRIAL PARK; cammo industrial park; blk. f, no.2, batam centre; batam, 29461 ; ID 29461
• Manufacturer Contact: chia chin yin ; 440 ang mo kio; industrial park 1; singapore, 56962-0 ; SN 569620
• MDR Report Key: 9085645
• MDR Text Key: 163551898
• Report Number: 3002807350-2019-00006
• Device Sequence Number: 1
• Product Code: FIE
• UDI-Device Identifier: 08888483005291
• UDI-Public: 08888483005291
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/22/2019,09/13/2019

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?: No
• Distributor Facility Aware Date: 08/19/2019
• Device Age: 7 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/22/2019
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 09/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2018
• 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
• Patient Age: 31 YR
• Patient Weight: 103