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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 955542
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/28/2020
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that approximately one hour into continuous veno-venous hemodialysis using a prismaflex control unit and a prismaflex m100 set, a 'main power lost alarm' was generated, followed by a ´malfunction: voltage out of range' alarm. It was reported that the prismaflex was plugged in securely to the red outlet. The treatment was ended without the extracorporeal (ec) blood being manually returned to the patient as clots were observed in the tubing. The amount of blood loss was not reported. It was reported the a blood transfusion was administered to patient. Further inspection observed that the plug connecting the power cord to the prismaflex machine inside the black plastic connector was not all the way plugged in to the back of the machine. This was corrected and treatment was re-started without further incidents. 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 Key10574908
MDR Text Key208204060
Report Number9616026-2020-00027
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K131516
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 09/23/2020,10/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number955542
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/23/2020
Distributor Facility Aware Date08/28/2020
Event Location Hospital
Date Report to Manufacturer09/23/2020
Date Manufacturer Received10/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/1900
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: 09/23/2020 Patient Sequence Number: 1
Treatment
PRISMAFLEX M100.
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