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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 113082
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/15/2018
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that ¿air bubbles came into the return side from the filter.¿ the reporter further stated that the prismaflex machine presented an air in line alarm, but the system did not automatically stop therapy.The therapy was discontinued with blood loss.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
The device was received for evaluation.A priming test and a simulated use test were performed, and both tests passed successfully with no issues noted.Treatment data was analyzed for the prismaflex control unit.Eleven (11) warning - access extremely negative alarms were issued between 01:19:15 and 01:25:37.This indicates that the vascular access was blocked for about 6 minutes and the operator was required to unblock it.Five (5) malfunction alarm - air detector alarms were issued between 01:26:17 and 01:26:54.When resolving the vascular access issue it is likely that air entered the circuit.That air was then transformed into foam when passing the filter.The foam emptied the deaeration chamber and reached the level of the air detector which caused the prismaflex control unit to issue the malfunction alarm - air detector.The operator choose to continue the treatment after adjusting the level in the deaeration chamber up.This review does not indicate any prismaflex control unit failure or that any air passed the air detector.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
PRISMAFLEX
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE - LUND MONITORS
lund skane lan
MDR Report Key7407663
MDR Text Key105305189
Report Number9616026-2018-00005
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K110823
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number113082
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2018
Initial Date Manufacturer Received 03/15/2018
Initial Date FDA Received04/09/2018
Supplement Dates Manufacturer Received06/05/2018
Supplement Dates FDA Received06/17/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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