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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION THERANOVA 400 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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BAXTER HEALTHCARE CORPORATION THERANOVA 400 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 955365
Device Problems Fluid Leak (1250); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/26/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter address: (b)(6). Initial reporter phone no. : (b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that there was external blood leakage through both poles of a theranova 400. The blood leak was observed during therapy. It was also reported that a slight fissure was discovered on the filter. The entire extracorporeal circuit and the filter were replaced. There was patient involvement however, no patient injury or medical intervention was reported. No additional information is available.
 
Event Description
It was reported that there was external blood leakage through both poles of a theranova 400. The blood leak was observed during therapy. It was also reported that a slight fissure was discovered on the filter. The entire extracorporeal circuit and the filter were replaced. There was patient involvement however, no patient injury or medical intervention was reported. No additional information is available.
 
Manufacturer Narrative
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NameTHERANOVA 400
Type of DeviceDIALYZER, 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 Key13063260
MDR Text Key286065283
Report Number9611369-2021-00369
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 01/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number955365
Device Lot Number1-6502-H-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/13/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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