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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTERLINK BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION

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BAXTER HEALTHCARE CORPORATION INTERLINK BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION Back to Search Results
Catalog Number 2C6700
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
G1: device manufacturer address 1: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the tubing detached from the filter chamber of an interlink straight type blood set.This was observed during an unspecified process step.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
H11: the actual device was not available; however, three (3) photographs of the sample were provided for evaluation.A visual inspection of the photographs was performed which identified a separation between the tubing and the blood filter chamber.The reported condition was verified.The cause of the condition could not be determined.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
INTERLINK BLOOD RECIPIENT SET
Type of Device
SET, BLOOD TRANSFUSION
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - CARTAGO
see h10
cartago 30106
CS   30106
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key19130675
MDR Text Key340485557
Report Number1416980-2024-01773
Device Sequence Number1
Product Code BRZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/23/2024
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 Other
Device Catalogue Number2C6700
Device Lot NumberR14G17011
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/25/2024
Initial Date FDA Received04/18/2024
Supplement Dates Manufacturer Received05/20/2024
Supplement Dates FDA Received05/23/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/17/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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