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

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.

• Brand Name: REVACLEAR 3000
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 10894488
• MDR Text Key: 218236438
• Report Number: MW5098051
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1