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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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BAXTER HEALTHCARE CORPORATION PRISMAX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 955558
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/11/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the patient fluid removal was accidentally set at 1,000 ml/hour instead of the pre-blood-pump to be set at that rate.The incorrect setting was noticed after a few hours.No symptom was reported, however, the patient was ordered extra fluid to compensate for the fluid removed.No additional information is available.
 
Manufacturer Narrative
Additional information: h3, h6 and h10.H10: the device was not returned, and the serial number is unknown; therefore a device analysis could not be completed, however, the reported event is considered verified based on event description.This is a known issue and is being further investigated.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
PRISMAX
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key11133544
MDR Text Key226031037
Report Number1416980-2020-08385
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
PMA/PMN Number
K190910
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number955558
Was Device Available for Evaluation? No
Date Manufacturer Received02/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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