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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number ASKU
Device Problems No Audible Alarm (1019); Improper or Incorrect Procedure or Method (2017)
Patient Problems Cardiac Arrest (1762); Blood Loss (2597)
Event Date 09/04/2020
Event Type  Injury  
Manufacturer Narrative
The event was reported to have occurred "in the last few months," facility name: (b)(6) medical center. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a patient's return blood line became disconnected from the catheter during continuous renal replacement therapy using a prismaflex set and a prismaflex control unit. During nursing handoff at beside, the patient's blood pressure was observed to be dropping. Upon assessing the patient, "a large amount of blood" was observed on the bed. The patient went into cardia arrest and needed resuscitation. The patient outcome was not reported. An alarm was not generated by the control unit. 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 CORPORATION
deerfield IL
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
2242702068
MDR Report Key10649902
MDR Text Key210594568
Report Number9616026-2020-00030
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/08/2020,11/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue 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 FDA10/08/2020
Distributor Facility Aware Date09/09/2020
Event Location Hospital
Date Report to Manufacturer10/08/2020
Date Manufacturer Received10/30/2020
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: 10/08/2020 Patient Sequence Number: 1
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