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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/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/16/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(6). The device was evaluated on site by a qualified technician. An evaluation of the equipment confirmed an alarm in the blackbox. Upon visual inspection, the qualified technician found a leakage at the u9000. To resolve the issue, the qualified technician replaced the u9000 and then the machine was running normally. Based on past investigations, the most likely failure is a crack in the housing nearby the welding zone. This is design related. This issue is being further investigated. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during self-check 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 Key14337050
MDR Text Key291215219
Report Number9611369-2022-00072
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,Followup
Report Date 06/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2022
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
Is the Reporter a Health Professional? No
Date Manufacturer Received05/03/2022
Was Device Evaluated by Manufacturer? Yes
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: 05/09/2022 Patient Sequence Number: 1
Treatment
AK 96
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