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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 955792
Device Problem Protective Measures Problem (3015)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/18/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during continuous renal replacement therapy (crrt) using a prismaflex control unit, an air in blood alarm was generated.The reporter ¿made pressure negative (-320)¿ and released the clamp, cleaned the air detector and checked for microbubbles; however, the alarm continued.Treatment was discontinued.The extracorporeal blood was not returned to the patient.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
Additional information: h6 and h10.A service history review was conducted and there were no deviations found related to this reported condition.The actual device was received for evaluation.The device was tested through a self test and a simulated treatment.The reported issue could not be confirmed.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 Key8700154
MDR Text Key183132540
Report Number9616026-2019-00035
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K131516
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
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 Received06/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number955792
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/20/2019
Date Manufacturer Received07/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NI.
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