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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEYZIEU; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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BAXTER HEALTHCARE - MEYZIEU; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number ASKU
Device Problems Disconnection (1171); Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The product is a prismaflex effluent bag the event was reported to have occurred on an unreported date in (b)(6) 2019.Initial reporter phone no.: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a 5l effluent bag, from a prismaflex set, had a connection issue.An unknown part of the bag disconnected resulting to 5 liter content leaking out.Patient involvement is unknown.No additional information is provided.
 
Manufacturer Narrative
The device was not received for evaluation, however, a photograph was received and inspected.The inspection revealed that the yellow valve of the sp-414u drain bag provided with the set was disconnected.The reported condition was verified.The cause was not determined.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
NI
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE - MEYZIEU
meyzieu cedex rhone
MDR Report Key8983376
MDR Text Key182050741
Report Number8010182-2019-00181
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 10/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received10/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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