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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL ACCESS; SET, BLOOD TRANSFUSION
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BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL ACCESS; SET, BLOOD TRANSFUSION Back to Search Results
Catalog Number JC7751
Device Problems Excess Flow or Over-Infusion (1311); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/22/2014
Event Type  malfunction  
Event Description
It was reported that a clearlink y-type set experienced overinfusion characterized as free flow.The reporter stated that it appeared that the roller clamp (white) was not clamping the tube sufficiently even though the roller ball was pulled down all the way.There was no patient injury or medical intervention associated with this event.Additional information was requested and is not available.
 
Manufacturer Narrative
(b)(4).The sample was not available for evaluation.Therefore, no analysis can be performed.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 - HAINA, SAN CRISTOBAL
parque industrial itabo, zona
haina
DR 
Manufacturer (Section G)
BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL
parque industrial itabo, zona
haina
DR  
Manufacturer Contact
christina arnt
25212 w. illinois route 120
round lake, IL 60073
2242703198
MDR Report Key3816619
MDR Text Key4394901
Report Number1416980-2014-15892
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 Foreign,Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/23/2014
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 Health Professional
Device Catalogue NumberJC7751
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/23/2014
Initial Date FDA Received05/19/2014
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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