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Adverse Event Report

B. BRAUN BRAUN ULTRASITE HORIZON PUMP IV SET   back to search results
Patient Outcome  Required Intervention;
Event Description

Leaking x2 with ultrasite iv set. Leaking just below the connector of the needleless injection site. First pt receiving bolus of fluid due to low urine output. Condition did not improve. Found puddle of fluid under bed. Pt required additional fluid. Second pt on dopamine infusion which had to be increased because of leak. Pt may have received more medication than necessary.

 
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Brand NameBRAUN
Type of DeviceULTRASITE HORIZON PUMP IV SET
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
B. BRAUN
bethlehem PA 18018
Device Event Key435015
MDR Report Key446049
Event Key422301
Report NumberMW1027708
Device Sequence Number1
Product CodeFPA
Report Source Voluntary
Report Date 03/04/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/04/2003
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
OTHER Device ID NumberREF # US3130
Was Device Available For Evaluation? No Answer Provided
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on January 30, 2009

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