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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. DIALYSIS MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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B. BRAUN MEDICAL INC. DIALYSIS MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Device Problems Device Alarm System (1012); Product Quality Problem (1506)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Dialysis machines, specifically b braun, and to a lessor extent fresenius machines recently my dialysis center changed from fresenius to b braun machines. With the following problems. All the alarms are different between the two noted machines. What this means is the nurses and techs all have to get used to different sounds of alarms to react to. Some are more important than others. This difference slows down reaction time so the alarms last longer. There is already enough noise in the room so adding to the din is annoying. It also means people transitioning between the two machines have slower reaction times. In times of emergency (katrina) this could be serious. Why aren't all alarms standardized? like typewriter keyboards. No matter what machine, the alarm for a specific function should sound the same. The numbering system for the profile of the dialysis is different between the machines. This is for the rate and removal of toxins over the time of dialysis. What was #2 for the fresenius machine is #11 for the b braun. Again, standardization would avoid contusion. Alarm placement. Fresenius is in the rear of the machine. B braun however is on the right (facing the machine) at a level about where your ear is in the recliners used at dialysis. Even noise-cancelling earphones don't work. These alarms need to be moved so that patients on either side of the machine don't have the alarms blaring in their ears. Better yet patients don't need to hear the alarms. With todays siu-tooth technology the alarms could be transmitted right to the nurses and techs who are responsible for the individual machines, quieting the whole dialysis environment and allowing the patients who have to be there for hours with needles stuck in their arms to maybe get some rest? your cooperation in considering these improvements (by mandate) would be greatly appreciated, as it is doubtful the manufactures would work together to do it on their own. I would also like to voice my opinion about another topic that might be in your area of expertise. I have noticed that to many of the supplies in these dialysis facilities ((b)(6) re-embursed) are supplied from (b)(4). Pre-packaged supplies being brought in from a country that is our enemy is a perfect way to help them initiate covid 20 or whatever the next pandemic is they decide to infect the world with. I for one do not want to be treated with supplies packaged in (b)(4). Anyone supplying a medical facility that receives any government funding should be required to source supplies from someone in the united states of america. I want my tax dollars to be in my neighbors paycheck, not the red chinese military.
 
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Brand NameDIALYSIS MACHINE
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
MDR Report Key13025863
MDR Text Key282831947
Report NumberMW5106135
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/28/2021
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received12/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided

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