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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 114604
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/02/2022
Event Type  malfunction  
Event Description
It was reported that before use with a u9000 ultrafilter, an external fluid leakage from cap was observed. It was further reported the product had been used for 46 days and had been disinfected for 48 times. There was no patient involvement. No additional information is available.
 
Manufacturer Narrative
The actual device was not available for evaluation; however, three photographs were provided for evaluation. Visual inspection of the first picture shows the head area of the ultrafilter. The product is out of the packaging and wet. The second picture shows the product with part of the product label (lot number and barcode are visible). Photo three shows the monitor screen. The reported condition was verified. The most likely cause of the condition could be due to a crack in the housing nearby the welding zone. A nonconformance has been opened to address this issue. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.
 
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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 Key14578037
MDR Text Key293263495
Report Number9611369-2022-00093
Device Sequence Number1
Product Code FIP
UDI-Device Identifier07332414114046
UDI-Public(01)07332414114046
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,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number114604
Device Lot Number1-1802-H-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/05/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/25/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/02/2022 Patient Sequence Number: 1
Treatment
AK 96
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