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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE CORPORATION PRISMAX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 955626
Device Problem Device Alarm System (1012)
Patient Problem Blood Loss (2597)
Event Date 12/12/2020
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that two hours into a continuous renal replacement therapy treatment with a prismax machine, a system failure, call service alarm and an access extremely negative alarm, were generated.The treatment was interrupted and the extracorporeal blood was not returned to the patient.Treatment was restarted with another prismax machine, resulting in additional blood loss and a blood transfusion.The patient outcome was not reported.No additional information is available.
 
Manufacturer Narrative
Correction: removal of information in section f related to importer - the initial report inadvertently indicated that the report was being submitted as an importer report.This mdr should have been submitted only as a manufacturer report (and not as an importer report).
 
Manufacturer Narrative
H9: 3003504604-04/21/21-001-c.H10: the device was inspected on site by a qualified baxter technician and the arps (automatic repositioning system segment) was replaced.A device history review revealed no issues that could have caused or contributed to the reported issue.The lox files were reviewed and the reported condition was verified.Should additional relevant information become available, a supplemental report will be submitted.H10: the device was inspected on site by a qualified baxter technician.A prime test and simulated self test were performed with no issues noted.A device history review revealed no issues that could have caused or contributed to the reported issue.The lox files did not identify any treatment for the reported event date.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
PRISMAX
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key11142771
MDR Text Key226008460
Report Number1416980-2020-08412
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00085412639499
UDI-Public(01)00085412639499
Combination Product (y/n)Y
PMA/PMN Number
K190910
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Notification
Type of Report Initial,Followup,Followup
Report Date 05/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number955626
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date12/14/2020
Event Location Hospital
Initial Date Manufacturer Received 12/14/2020
Initial Date FDA Received01/08/2021
Supplement Dates Manufacturer Received03/18/2021
05/21/2021
Supplement Dates FDA Received03/23/2021
05/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
AUTO EFFLUENT SET; PRISMAFLEX SET; PRISMASOL SOLUTION; THERMAX POUCH
Patient Outcome(s) Required Intervention;
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