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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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BAXTER HEALTHCARE CORPORATION PRISMAFLEX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 114870
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 10/20/2020
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during preparation and before use with a prismaflex machine, the front wheel was found damaged.To resolve the issue, the qualified technician performed front wheel adjustment (front wheel was found loose during inspection).There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
H10: the device was evaluated on site, by a qualified technician inspected the device and observed the front wheel to be loose.The reported condition was verified.A front wheel adjustment was performed.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.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 CORPORATION
deerfield IL
MDR Report Key10817807
MDR Text Key220242414
Report Number9616026-2020-00034
Device Sequence Number1
Product Code KDI
UDI-Device Identifier07332414115395
UDI-Public(01)07332414115395
Combination Product (y/n)Y
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number114870
Was Device Available for Evaluation? No
Date Manufacturer Received11/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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