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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 955724
Device Problems Device Alarm System (1012); Unexpected Shutdown (4019)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/07/2022
Event Type  Injury  
Event Description
It was reported that a patient experienced two blood loss events requiring blood transfusions during continuous renal replacement therapy (crrt) with a prismax control unit. At an unknown time during therapy, an unspecified error occurred and the device shut down. The extracorporeal blood was not returned to the patient. The patient became unstable and was transfused with one unit of red blood cells. A second treatment was initiated and while changing the dialysis and replacement bags, the control unit began to screech and the screen went blank. The screen came back on, however, the screeching continued until "a red button" was pressed. The control unit rebooted and an alarm b1404 (current of backup speaker out of range) was generated. The extracorporeal blood was not returned to the patient and a blood transfusion was performed within less than twenty four hours. No additional information is available.
 
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NamePRISMAX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - MEDOLLA MODENA MONITORS
via modenese, 66
medolla modena 41036
IT 41036
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key13710832
MDR Text Key290540834
Report Number9616240-2022-00002
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K193482
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number955724
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/02/2022
Was Device Evaluated by Manufacturer? No
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: 03/09/2022 Patient Sequence Number: 1
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