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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ULTRAFILTER HECHINGEN SUBSYSTEM, WATER PURIFICATION

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BAXTER HEALTHCARE CORPORATION ULTRAFILTER HECHINGEN SUBSYSTEM, WATER PURIFICATION Back to Search Results
Catalog Number ASKU
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/29/2022
Event Type  malfunction  
Manufacturer Narrative
The device was not received for evaluation; therefore, a device analysis could not be completed. A potential cause of the condition could have been a crack in the housing nearby the welding zone. A nonconformance has been established to further investigate. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported during priming with a u9000 filter, a water leak was observed. There was no patient involvement. No additional information is available.
 
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Brand NameULTRAFILTER HECHINGEN
Type of DeviceSUBSYSTEM, WATER PURIFICATION
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 Key14159863
MDR Text Key290463770
Report Number9611369-2022-00064
Device Sequence Number1
Product Code FIP
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received03/29/2022
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 Initial

Patient Treatment Data
Date Received: 04/20/2022 Patient Sequence Number: 1
Treatment
AK 98
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