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Adverse Event Report

BAXTER HEALTHCARE CORP. ELECTRONIC INFUSION SYS. PCA INFUSION PUMP - PATIENT CONTROLLED   back to search results
Patient Outcome  Other;
Event Description

Pt was put on morphine to be administered by pca infusion pump. Pump values indicated that the medication was dispensed. Eight hours later it was discovered that the plunger had malfunctioned, and that the syringe was full and no morphine was administered.

 
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Brand NamePCA
Type of DeviceINFUSION PUMP - PATIENT CONTROLLED
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
BAXTER HEALTHCARE CORP. ELECTRONIC INFUSION SYS.
rt 120 & wilson rd.
round lake IL 60073
Device Event Key98522
MDR Report Key100002
Event Key94045
Report NumberMW1011543
Device Sequence Number1
Product CodeMEA
Report Source Voluntary
Report Date 06/17/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/24/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? Yes
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on February 28, 2009

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