MAUDE Adverse Event Report: JMS SINGAPORE PTE LTD SYSLOC MINI AVF 1 5GX1" BE 30CM W/CLAMP; JMS SYSLOC MINI A.V. FISTULA NEEDLE SET

Model Number 864-1500-33

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Exsanguination (1841); Hypovolemia (2243); Blood Loss (2597)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 180830331.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.As per the information provided by facility and (b)(4), no defect or malfunction was observed of the jms sysloc mini avf.Hence, this incident is not related to our manufacturing process.Nonetheless, briefing was conducted on 26 dec 2018 to all related operators and inspectors for their awareness on the reported defect.(b)(4).

Event Description

On (b)(6) 2018, a hemodialysis patient, arrived to treatment; pre-dialysis vs obtained b/p 153/77; pulse 86; resp 17; temp 97.8.Approximately 2 hours into the scheduled 4 hour hemodialysis treatment vs obtained were: b/p 97/52; pulse 84.The ultrafiltration was turned off and the patient's legs were elevated.The machine subsequently alarmed venous pressure and the blood pump stopped.The patient was lethargic and slow to respond verbally with the venous needle dislodged with the tape intact on the wings of the needle.Blood was noted to be flowing down the inside of the chair; a puddle of blood was under the chair.Estimated blood loss (ebl) was 1 unit.Approximately 400 mls normal saline was administered.Ems was called.Upon discharge from the facility via ems, patient was oriented with b/p 102/64; pulse 118.The patient was admitted to the hospital.1 unit of pack red blood cells (prbcs) was infused in the er.

• Brand Name: SYSLOC MINI AVF 1 5GX1" BE 30CM W/CLAMP
• Type of Device: JMS SYSLOC MINI A.V. FISTULA NEEDLE SET
• Manufacturer (Section D): JMS SINGAPORE PTE LTD; 440 ang mo kio industrial pk 1; singapore, 56962 0; SN 569620
• Manufacturer (Section G): PT. JMS BATAM; lot 211 jalan beringin; batmindo ind.park muka kuning; indonesia, ; ID
• Manufacturer Contact: chia chin yin ; 440 ang mo kio industrial pk 1; singapore, 56962-0 ; SN 569620
• MDR Report Key: 8243182
• MDR Text Key: 132919528
• Report Number: 3002807350-2018-00012
• Device Sequence Number: 1
• Product Code: FIE
• UDI-Device Identifier: 08888483005567
• UDI-Public: 08888483005567
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/24/2018,12/06/2018

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: 08/30/2023
• Device Model Number: 864-1500-33
• Device Lot Number: 180830331
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/24/2018
• Device Age: 4 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/24/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/14/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/30/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 77 YR
• Patient Weight: 80