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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Myocardial Infarction (1969)

Event Date 09/11/2021

Event Type  Death  

Event Description

(b)(6) had kidney dialysis at (b)(6) hospital and had a heart attack he was told to take dialysis to get a heart surgery but he had a really bad kidney disease.He was visiting the (b)(6) hospital because of heart attack.They never attend his medical history from the (b)(6) put them on kidney dialysis lead to death.Fda safety report id# (b)(4).

• Brand Name: KIDNEY DIALYSIS
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• MDR Report Key: 12727827
• MDR Text Key: 279559638
• Report Number: MW5105027
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 10/28/2021

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 64 YR
• Patient Weight: 91