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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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BAXTER HEALTHCARE CORPORATION PRISMAFLEX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 955792
Device Problem Protective Measures Problem (3015)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/09/2021
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during continuous renal replacement therapy using a prismaflex control unit , the device issued an excessive transmembrane pressure alarm due to automatic repositioning system (arps) tubing failure.There was blood loss reported, however the amount was not specified.The patient was transfused.The patient outcome was not reported.No additional information is available.
 
Manufacturer Narrative
H10: a service history review determined that similar events occurred on this machine where a qualified baxter technician replaced the arps tubing.The device was not available for evaluation.The cause of the event based on complaints review is determined to be due to a part failure.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
PRISMAFLEX
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key11620193
MDR Text Key243977241
Report Number9616026-2021-00016
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
PMA/PMN Number
K131516
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 04/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number955792
Was Device Available for Evaluation? No
Date Manufacturer Received05/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NI.
Patient Outcome(s) Required Intervention;
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