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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - LUND MONITORS PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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BAXTER HEALTHCARE - LUND MONITORS PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Low Blood Pressure/ Hypotension (1914)
Event Type  Injury  
Manufacturer Narrative
Date of event: the events occurred on an unspecified dates during (b)(6) 2018. (b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during continuous renal replacement therapy (crrt) using a prismaflex control unit, an unknown number of patients experienced ¿severe, dangerous blood pressure drops that are not transient¿. The reporter stated the blood pressure drops were associated with user error. No further information was provided regarding "blood pressure drop" details, treatment or medical interventions for the events. At the time of this report, the patient outcomes were not reported. No additional information is available.
 
Manufacturer Narrative
The device was not returned and the serial number remains unknown; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NamePRISMAFLEX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE - LUND MONITORS
lund skane lan
MDR Report Key8583330
Report Number9616026-2019-00026
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/06/2019,06/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/06/2019
Distributor Facility Aware Date04/11/2019
Event Location Hospital
Date Report to Manufacturer05/06/2019
Date Manufacturer Received06/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Treatment(s)
DIALYSATE/REPLACEMENT FLUIDS; PRISMAFLEX M100 SET; DIALYSATE/REPLACEMENT FLUIDS; PRISMAFLEX M100 SET
Patient Outcome(s) Other;
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