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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 05/26/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(6). The device was not received for evaluation; however, the device was evaluated on site by a qualified technician. Upon evaluation a leakage was identified. To resolve the issue, the qualified technician replaced the u9000. The reported condition was verified. The cause of the condition could not be determined; however, the most likely cause is a crack in the housing nearby the welding zone. A nonconformance has been opened to address this issue. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during disinfection with the u9000 filter, an external fluid leakage 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 - LUND MONITORS
magistratsvagen 16
lund skane lan SE-22 643
SW SE-22643
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key14754115
MDR Text Key303163368
Report Number9616026-2022-00059
Device Sequence Number1
Product Code FIP
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2022
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 Received05/27/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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