MAUDE Adverse Event Report: HEMODIALYSIS UNIT; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Death  

Event Description

(b)(6) 2016, (exact date unknown), a stable patient receiving routine dialysis at (b)(6) center in (b)(6) died during routine weekly dialysis because her needles became dislodged and she bled out and died.This is a result of lack of following known protocols of keeping arms exposed, taking bp every half hour, and always having an assigned tech or nurse over each patient.I wish to report a repeated practice by the regional manager, (b)(6), of (b)(6) of hiring drug and alcohol impaired administrative nurses to be in charge of dialysis units.I have worked at one of them for 3 and a half years before resigning in 2018.These administrative nurses have varying degrees of ability to perform hands on patient care and are a constant risk for a vulnerable population.Many times the patients to not receive prescribed medications and follow up blood lab draws which put them at high risk particularly blood potassium levels.These administrators include (b)(6), who has been employed at (b)(6) for over 20 years, (b)(6) is drunk, smelling strongly of alcohol, and nonfunctional by 10:00 am.(b)(6) and others.State reviewers for (b)(6)arrived one day at a (b)(6) site for review and all of them and the nurses left the site before they arrived.They were appointed to facility administrators for various units following this.An employee called police on (b)(6) following a physical altercation and he was tested for drugs in urine, tested positive and was terminated.(b)(6) remains regional manager.This complaint is not about a medical device or medication.It is about a very dangerous practice of appointing dangerously impaired employees to the care of vulnerable patient population.I wish to not reveal my identity as i have been threatened by regional manager, (b)(6).These incidents compromise all patients receiving hemodialysis.Fda safety report id # (b)(4).

• Brand Name: HEMODIALYSIS UNIT
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• MDR Report Key: 12210584
• MDR Text Key: 263224988
• Report Number: MW5102681
• Device Sequence Number: 1
• Product Code: KDI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2021

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening