MAUDE Adverse Event Report: NIPRO CORP DIAMAX NIPRO HEMO MACHINE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Chest Pain (1776); Dyspnea (1816)

Event Type  Injury  

Event Description

The employee (clinica (b)(6)) (b)(6) related that the equipment diamax did not detected air presence in the equipment, this occurred when the patient used the equipment.The patient related chest pain and difficult to breath.Machine available.There is patient involvement, and patient injury occurred.Patient injury reported: yes, medical intervention required: unknown (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DIAMAX NIPRO HEMO MACHINE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): NIPRO CORP
• MDR Report Key: 17526152
• MDR Text Key: 321100488
• Report Number: MW5133092
• Device Sequence Number: 1
• Product Code: KDI
• 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: 02/14/2012

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