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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
Model Number ASKU
Device Problem Device Displays Incorrect Message (2591)
Patient Problem Blood Loss (2597)
Event Date 01/14/2019
Event Type  Injury  
Manufacturer Narrative
The sample was not returned and the lot number of the device was unknown; therefore, a sample analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a blood leak detection alarm was generated on a prismaplex machine during treatment. After unsuccessful troubleshooting the treatment was ended without returning the extracorporeal blood to the pediatric patient. There was no patient injury or medical intervention associated with this event. 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 SE-22 643
SW SE-22643
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
MDR Report Key8316339
MDR Text Key135400984
Report Number9616026-2019-00004
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/07/2019
Distributor Facility Aware Date01/14/2019
Event Location Hospital
Date Report to Manufacturer02/07/2019
Date Manufacturer Received01/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 02/07/2019 Patient Sequence Number: 1
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