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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - TIJUANA BAJA CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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BAXTER HEALTHCARE - TIJUANA BAJA CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
Catalog Number 101025
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 11/22/2019
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during priming with 2 units of exeltra 150 dialyzer and a gambro cartridge dn prime line, there was a clear particulate matter observed in the saline solution inside the chambers in the blood lines.The particulate matter allegedly dissolved, but the dialyzers were not used for patient treatment.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
Additional information: h6 and h10.The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
CARTRIDGE
Type of Device
SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
Manufacturer (Section D)
BAXTER HEALTHCARE - TIJUANA BAJA
deerfield IL
MDR Report Key9494499
MDR Text Key219387892
Report Number8030638-2019-00020
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
PMA/PMN Number
K070414
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/22/2019,01/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number101025
Was Device Available for Evaluation? No
Distributor Facility Aware Date11/22/2019
Event Location Hospital
Date Report to Manufacturer11/22/2019
Date Manufacturer Received01/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
EXELTRA 150 DIALYZERS (NON BAXTER PRODUCT)
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