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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION REVACLEAR 3000 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE CORPORATION REVACLEAR 3000 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Device Problem Protective Measures Problem (3015)
Patient Problem Reaction (2414)
Event Date 05/27/2019
Event Type  Injury  
Event Description
My name is (b)(6). I am a nurse at the (b)(6) medical center, (b)(6). I would like to report an incident where a patient/(b)(6) was harmed on (b)(6) 2019 while on hemodialysis. I was her dialysis nurse that day. We found out after i completed her treatment, that there was blood in dialysate. She suffered severe reaction post treatment. The hospital does not have a policy and procedure regarding this event. I am not sure why there was not an alarm to notify me of "blood in dialysate", i called baxter and told them what had happened. They told me this incident has to be reported. I asked them why the hospital did not contact them? they told me because it was not required. Baxter's emailed me asking for specific details regarding the incident, i told them i do not know. I forwarded their email to the director of hemodialysis dept. Told baxter, if i would have forwarded the email to my boss, she would have thrown it out. My boss had told me they "investigated" the machine. But 3 other nurses told me the data on the hd machine were deleted. I read online there were recalled regarding the "revaclear 3000" which (b)(6) was using. That same patient came down to hd 2 days later, and they used the same dialysate/revaclear 3000. When my boss/(b)(6) found out i called baxter, she threatened to take me to human resources. She told me i had no right to call baxter. I was summoned to hr and was told that my progress note and the event report that i wrote was "unprofessional" and "inappropriate". They stated that it is "discoverable" in the state of (b)(6). Now, they have tarnished my employment record. I ask that you do not release my name to the hospital for reporting this event. Thank you for your time. If you have further questions, you can contact me at (b)(6). Reference 9616240-2019-00005.
 
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Brand NameREVACLEAR 3000
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
MDR Report Key10894488
MDR Text Key218236438
Report NumberMW5098051
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/29/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

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