MAUDE Adverse Event Report: JMS NEEDLE, FISTULA

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Impaired Healing (2378)

Event Type  Death  

Event Description

On (b)(6) 2018 a hemodialysis (hd) patient, (initials: (b)(6), date of birth: (b)(6) 1936, gender: female, estimated dry weight: 111.50kg), completed a scheduled hd treatment without any issues but was later found bleeding in their car and subsequently expired.The treatment started at 5:50am on (b)(6) 2018 and ended at 9:53am.Post-dialysis vitals and evaluation: post-weight 11 l.30kgs, weight change -3.Iokgs, bp sitting 151/71, bp standing 115-53, pulse 78r, respirations 18, temperature 97.2f.The patient was fully re-infused post treatment.The patient's access site was intact positive for thrill and bruit and the patient ambulated to the scale independently.The patient had no issues during or after treatment.There were no allegations of any fresenius device or product malfunction, or of any hd product issue that was used during the patient's treatment that day.The patient was discharged to home following treatment.The patient drives to the clinic herself.The patient left the clinic around 10:15am without any known issues.It was unknown what the patient had done after she left the clinic.It was very cold outside that day and the patient was wearing heavy jacket.At some point while out driving her car after treatment, the patient noticed blood leaking from her fistula and pulled over and stopped and called 911 (ems).The source of the blood loss was from her av fistula (upper arm/brachial-basilic, right).Emergency team found her in her car and took her to the hospital, but she expired that day.It is unknown if the patient expired in her car or during transport to/at the hospital.It was reported that there was poor healing of the needle sites (scabbing) regarding the patient's fistula.There have been no errors or issues with anticoagulant therapy during treatment prior to the event.The patient does not have a history of any bleeding disorders.N/a.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: NEEDLE, FISTULA
• Type of Device: NEEDLE, FISTULA
• Manufacturer (Section D): JMS
• MDR Report Key: 17536602
• MDR Text Key: 321041812
• Report Number: MW5143487
• Device Sequence Number: 1
• Product Code: FIE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1