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

Device Problem Gas/Air Leak (2946)

Patient Problems Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Nausea (1970)

Event Type  Injury  

Event Description

Correspondence was received from baxter marketing, of a report from sanford health bemidji, mn of a male patient who reportedly experienced shortness of breath (sob), hypotension, and health, nausea after an air in line alarm occurred 5 minutes after the start of hemodialysis on an unknown date using max dialyzer and gambro tubing.The patient was reportedly treated with normal saline (ns) (rate and revaclear unknown), oxygen (unknown liter flow), reglan (dose and route unknown), and tilting the patient's chair amount backwards.Therapy was continued and the symptoms reportedly subsided with no further problems.The physician was notified.The revaclear max dialyzer and gambro tubing were saved by the gambro has been notified of this event and indicated they are investigating and facility.Will report on the event.Patient injury reported: yes, medical intervention required: yes (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: UNKNOWN
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO
• MDR Report Key: 17531806
• MDR Text Key: 321144125
• Report Number: MW5138717
• 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: 02/21/2012

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