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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
Catalog Number 2C8750
Device Problem Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/28/2014
Event Type  malfunction  
Event Description
It was reported that the tubing of a clearlink blood solution set disconnected from the drip chamber.This occurred while a patient was receiving treatment.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
(b)(4).The unknown lot number could have been produced in either aibonito or the dominican republic.The addresses for both manufacturing sites are: (b)(4).The device was not returned and the lot number is unknown; therefore, an evaluation could not be conducted.Should additional relevant information become available, a supplemental report will be submitted.
 
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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
christina arnt
25212 w. illinois route 120
round lake, IL 60073
2242703198
MDR Report Key4184560
MDR Text Key5093699
Report Number1416980-2014-36542
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
Report Date 06/06/2014
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 Number2C8750
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/06/2014
Initial Date FDA Received10/20/2014
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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