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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

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BAXTER HEALTHCARE CORPORATION CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
Catalog Number 103401
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/04/2020
Event Type  malfunction  
Manufacturer Narrative
Initial reporter address: (b)(6).Phone number: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that approximately about three hours and 40-50 minutes after starting dialysis treatment with a gambro cartridge set, an external blood leak was observed from the venous patient connector.The volume of the blood loss was not reported.The treatment was stopped and the extracorporeal blood was returned to the patient.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
The actual device was not available; however, two photographs were provided for evaluation.The inspection of the photographs and eight retained samples did not verify the reported condition.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 Name
CARTRIDGE
Type of Device
SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key10102721
MDR Text Key241010575
Report Number8030638-2020-00006
Device Sequence Number1
Product Code FJK
UDI-Device Identifier07332414007867
UDI-Public(01)07332414007867
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,foreig
Type of Report Initial,Followup
Report Date 07/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/15/2022
Device Catalogue Number103401
Device Lot Number1000247401
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/04/2020
Initial Date FDA Received05/29/2020
Supplement Dates Manufacturer Received06/30/2020
Supplement Dates FDA Received07/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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