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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

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BAXTER HEALTHCARE - LUND MONITORS PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 113874
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Exsanguination (1841); Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418)
Event Date 08/29/2019
Event Type  Injury  
Manufacturer Narrative
(b)(6). A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event. The event history log review showed that the control unit correctly identified a significant return pressure drop and issued a ¿return pressure dropping¿ warning alarm. The data recorded in the log file confirm that it was a result of a disconnection of the return connection and exclude that the alarm is a result of a machine malfunction. The treatment was resumed by the operator four seconds later, despite ¿return pressure dropping¿ warning and the prismaflex machine having switched to patient safety mode. The machine was inspected by the clinical engineering team of the hospital; no issues were identified and the machine was found to perform as per specifications. The cause for exsanguination of the patient was that the operator failed to troubleshoot the return line disconnection from the catheter before resuming the treatment. The prismaflex user¿s manual warns the operator the after a warning: return pressure dropping the line has to be inspected for ¿possible leakage or disconnection of return line or catheter. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during continuous veno-venous hemofiltration (cvvh), a visual alarm was issued by the prismaflex control unit, indicating that there was a problem with pressures but there was no audible alarm. A nurse went to investigate the alarm and noticed that the patient had exsanguinated into the bed and on to the floor due to the return line, which was directly connected to the catheter, becoming disconnected from the vascath. The machine was immediately stopped and the vascath lines were clamped. No defects were observed on the set or catheter (vygon dualysecathexpert). The patient became hypotensive and unresponsive. The arrest trolley was acquired and the defibrillator pads were applied. Fluid resuscitation was commenced at the same time. A non rebreather oxygen mask was applied on the patient. The patient's airway and breathing did not become compromised. A unit of red blood cells was administered. The patient's blood pressure and glasgow coma scale improved after a few minutes. 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 - LUND MONITORS
deerfield IL
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 Key9364286
MDR Text Key184178783
Report Number9616026-2019-00060
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K110823
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number113874
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 Received10/28/2019
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: 11/22/2019 Patient Sequence Number: 1
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