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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 07/07/2022
Event Type  malfunction  
Event Description
It was reported that during priming with a u9000 filter, an external leak was observed.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
(b)(6).The device was evaluated by an onsite qualified technician.Visual inspection noted a the leak.The reported condition was verified.To resolve the issue, the qualified technician replaced the filter and no further issues were noted.The cause of the condition could not be determined; however, the most likely cause is due to a crack in the housing nearby the welding zone.Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
H10: the device was not received for evaluation; however, the qualified technician observed the u9000 leaking onsite.The reported condition was verified.To resolve the issue, the qualified technician replaced the u9000 with no issues noted.The most likely cause of the condition is due to 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.
 
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Brand Name
ULTRAFILTER HECHINGEN
Type of Device
SUBSYSTEM, 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 Key15147603
MDR Text Key300893786
Report Number9611369-2022-00135
Device Sequence Number1
Product Code FIP
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 Other
Type of Report Initial,Followup
Report Date 08/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/18/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
AK 98
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