• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BAXTER HEALTHCARE CORPORATION PRISMAX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 955558
Device Problem Protective Measures Problem (3015)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/01/2021
Event Type  Injury  
Manufacturer Narrative
(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 prismax machine, a patient experienced blood loss, resulting in a blood transfusion. Upon initiation of therapy a ¿syringe not detected¿ alarm occurred. The syringe was unloaded and reloaded, but the alarm persisted. The user also observed "small air bubbles" in the "replacement line running along the side the arterial line". Troubleshooting attempt was successful. Air was additionally observed in the arterial line, that was allegedly "causing froth due to intermittent extreme negative pressure alarms". The alarm for access pressure extremely negative was associated with a "problematic" vascular catheter. The alarm was resolved and treatment was continued, however, each time this alarm was triggered, a vacuum of air was generated by the negative pressure within the access line resulting in micro air bubbles to form when it came in contact with blood in the line. It was reported that the filer clotted resulting in a blood loss of approximately 250 ml as the machine would not allow the nurses to return the patient's blood. The nurses made a second attempt at getting the patient up and running on crrt and all the same problems happened again resulting in further patient blood loss (approximately 250 ml). A blood transfusion was performed. The patient outcome was not reported. No additional information is available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 - BROOKLYN PARK
7601 northland drive
n suite 170
minneapolis MN 55428
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key13177926
MDR Text Key288496083
Report Number3003504604-2021-00012
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number955558
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/09/2022
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 Initial

Patient Treatment Data
Date Received: 01/06/2022 Patient Sequence Number: 1
Treatment
VASCULAR CATHETER
-
-