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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
Catalog Number 113082
Device Problem Device Displays Incorrect Message (2591)
Patient Problem Death (1802)
Event Type  malfunction  
Manufacturer Narrative
The device was received for evaluation. Visual inspection did not identify any abnormalities that could have contributed to the reported condition. A review of the event history log was performed and revealed that the device had presented a pbp scale alarm. Functional testing and electrical safety testing were performed with no issues noted. Simulated use testing was performed, and the device was found to correctly present an alarm when the pbp bag was moved. The reported alarm was identified during evaluation; however, the device was found to be operating per specification. A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event. Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
This is a report of a patient who was prescribed continuous renal replacement therapy (crrt) using a prismaflex machine. While the patient was connected to the device the machine was moved and the monitor subsequently displayed an unspecified error alarm related to a ¿scale issue. ¿ it was reported that following the error message, the device operator tried to put the machine in patient mode but the device was no longer functional. The patient did not receive the treatment and reportedly died later the same day (cause of death not reported). 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 - LUND MONITORS
lund skane lan
Manufacturer (Section G)
BAXTER HEALTHCARE - LUND MONITORS
magistratsvagen 16
lund skane lan 22643
SW 22643
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key6826807
MDR Text Key105926332
Report Number9616026-2017-00058
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeCI
PMA/PMN Number
K110823
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 11/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number113082
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/12/2021
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: 08/29/2017 Patient Sequence Number: 1
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