Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL ACCESS; SET, BLOOD TRANSFUSION
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL ACCESS; SET, BLOOD TRANSFUSION Back to Search Results
Catalog Number JC7751
Device Problem Reflux within Device (1522)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/19/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device was discarded 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 blood backflowed through a clearlink y-type blood set.The set was attached to the medial port of a central venous access device.Fresh frozen plasma and platelets were being infused.The device was clamped when blood backflow occurred.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
kinga almasan
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key5371401
MDR Text Key36217823
Report Number1416980-2016-01161
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 01/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2016
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
Date Manufacturer 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
-
-