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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ACCESS; SET, BLOOD TRANSFUSION
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BAXTER HEALTHCARE CORPORATION ACCESS; SET, BLOOD TRANSFUSION Back to Search Results
Device Problems Filling Problem (1233); Improper Flow or Infusion (2954)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).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.
 
Event Description
It was reported that the unknown baxter blood set was being used when simultaneous flow was observed.The nurse clamped off the normal saline, but the normal saline continued to infuse at the same time as the blood.The infusion took longer than expected and the patient received 500 cc's more of the normal saline.There was no report of patient injury, medical intervention or adverse event associated with this event.No additional information is available.
 
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Brand Name
ACCESS
Type of Device
SET, BLOOD TRANSFUSION
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
Manufacturer (Section G)
BAXTER HEALTHCARE CORPORATION
Manufacturer Contact
kinga almasan
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key5324575
MDR Text Key34279269
Report Number1416980-2015-45539
Device Sequence Number1
Product Code BRZ
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 12/23/2015
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
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/10/2015
Initial Date FDA Received12/23/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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