• 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 - LUND MONITORS PRISMAFLEX 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 - LUND MONITORS PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 955052
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Shock (2072); Blood Loss (2597)
Event Date 05/22/2019
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a use error occurred while a patient was being treated with continuous renal replacement therapy (crrt) using a prismaflex control unit and a prismaflex set in addition with an ecmo machine piggybacked onto the prismaflex extracorporeal circuit. The event occurred in the intensive care unit where the patient was being treated for an unrelated critical illness. The use error was further described as the operator, when prompted by the prismaflex to replace the dialysate bag, erroneously pushed the wrong button to stop treatment and then unloaded the set whilst the patient was still connected; all applicable warning/safety messages were overridden by the operator. As a result, the patient¿s blood was drained into the fluid bags and the patient went into shock and the bags were quickly clamped. Resuscitation measures which included blood transfusion, was successful and crrt was restarted. At the time of this report the patient's condition was reported as still critically ill. No additional information is available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8707905
MDR Text Key148299583
Report Number9616026-2019-00036
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number955052
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/05/2019
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: 06/18/2019 Patient Sequence Number: 1
Treatment
ECMO MACHINE
-
-