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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX SET; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX SET; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number ASKU
Device Problem Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/29/2019
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 a prismaflex set had ¿the dialysate bag connection came loose¿ and air was entering the circuit during continuous veno-venous hemodiafiltration treatment on a pediatric patient.There was patient involvement, but no adverse event and medical intervention were reported.No additional information was provided.
 
Manufacturer Narrative
The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
PRISMAFLEX SET
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE - MEYZIEU
meyzieu cedex rhone
MDR Report Key8726914
MDR Text Key148964249
Report Number8010182-2019-00149
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/24/2019,07/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2019
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/24/2019
Distributor Facility Aware Date05/29/2019
Event Location Hospital
Date Report to Manufacturer06/24/2019
Date Manufacturer Received07/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PRISMAFLEX MACHINE; PRISMAFLEX MACHINE
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