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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION THERANOVA 500; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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BAXTER HEALTHCARE CORPORATION THERANOVA 500; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 955366
Device Problems Break (1069); Fluid/Blood Leak (1250); Component Missing (2306)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/24/2021
Event Type  malfunction  
Manufacturer Narrative
Phone number: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that before patient use, two units of theranova 500 had a missing dialysis connectors and one unit was observed to be broken resulting in a fluid leak.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The actual sample and pictures were provided for investigation.The visual inspection of the eight provided photos showed the unpacked product.The photos showed the product (header area) with a broken dialysate port.The last two photos also show the part of the broken dialysate port.The visual inspection by naked eye of the actual product showed two products dry and one product wet.On all three products, the dialysate port was observed to have broken off.The reported condition was verified.For the two dry products the residual part of the dialysate port was not available.On the wet product, the broken dialysate port had a heavy damage at the opening of the dialysate port.The cause could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
THERANOVA 500
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER
holger - crafoord - strasse 26
hechingen D-723 79
GM   D-72379
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key13315494
MDR Text Key284192014
Report Number9611369-2021-00391
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number955366
Device Lot Number0-6552-H-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received03/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NA.
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