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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 115269
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Low Blood Pressure/ Hypotension (1914)
Event Date 11/03/2020
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 veno-venous hemodialysis (cvvhd), a patient experienced decompensation with a drop in blood pressure. The patient was connected to a prismaflex control unit. It was reported that the patient fluid removal rate (pfr) was set to 240 ml/h prior to starting therapy, but when attending the patient who started to decompensate, the pfr was observed to have increased to 2000 ml/h. The operator claimed that no change had been made in the pfr. However, review of treatment history showed that the pfr had in fact been set to 2000 ml/h. Approximately twenty (20) minutes of the patient presenting with symptoms, the pfr was reset to zero and the patient was treated with albumin. Review of the treatment history also identified that the treatment had been performed in dialysis mode (cvvhd) whereas hemodiafiltration (cvvhdf) was prescribed for the patient. No additional information is available.
 
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Brand NamePRISMAFLEX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - LUND MONITORS
magistratsvagen 16
lund skane lan SE-22 643
SW SE-22643
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key10920059
MDR Text Key218714173
Report Number9616026-2020-00035
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K131516
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/30/2020,03/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number115269
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/30/2020
Distributor Facility Aware Date11/03/2020
Event Location Hospital
Date Report to Manufacturer11/30/2020
Date Manufacturer Received03/18/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 11/30/2020 Patient Sequence Number: 1
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