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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 06/21/2022
Event Type  malfunction  
Event Description
It was reported that during use with a u9000, an external fluid leakage was observed. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
 
Manufacturer Narrative
Initial reporter address: (b)(6). The actual device was not available; however, three photographs of the sample were provided for evaluation. Visual inspection of the provided picture shows in photograph number one the product out of the packaging with part of label. The second photograph shows the barcode is visible and the product is wet. Photograph three shows the product from a further distance with part of the product label. The reported condition was verified. The most likely cause of the condition is due to a crack in the housing nearby the welding zone. 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 Key15053861
MDR Text Key296384760
Report Number9611369-2022-00120
Device Sequence Number1
Product Code FIP
UDI-Device Identifier07332414114046
UDI-Public(01)07332414114046
Combination Product (y/n)N
Reporter Country CodeCH
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 Nurse Practitioner
Type of Report Initial
Report Date 07/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number114604
Device Lot Number1-1801-H-01
Was Device Available for Evaluation? No
Date Manufacturer Received06/24/2022
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: 07/19/2022 Patient Sequence Number: 1
Treatment
AK96 MACHINE
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