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Adverse Event Report

BAXTER HEALTHCARE CORP. INFUSION PUMP   back to search results
Model Number 6201
Event Description

Device was being used on a premature newborn. There was an overinfusion. Iv rate was set at 7. 8 cc/hr. At 0455 pump read: 30. 6 cc and buretrol read: 20 cc. At 0615 pump read: 40. 3 cc and buretrol read 3 cc. Pump=9. 7 cc infused and buretrol=17 cc. Tubing set up inspected for leaks and none were found.

 
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Brand NameINFUSION PUMP
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
BAXTER HEALTHCARE CORP.
round lake IL 60073
Device Event Key11735
MDR Report Key11735
Event Key7793
Report NumberMW1000877
Device Sequence Number1
Product CodeFRN
Report Source Voluntary
Report Date 02/17/1994
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/24/1994
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Invalid Data
Device MODEL Number6201
Was Device Available For Evaluation? Yes
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on February 28, 2009

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