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Adverse Event Report

ABBOTT LABORATORIES OMNI-FLOW 4000 PLUS INFUSION PUMP   back to search results
Catalog Number 40051
Event Date 06/23/1997
Event Type  Malfunction   Patient Outcome  Other;
Event Description

Overdelivery due to incorrect rate setting reported. The nurse states the pump was set to infuse a hydration fluid via line a at 50ml/hr and on either line b or line c (specific one not recalled) was cardizem 125mg/100ml at a rate of 10ml. Hr. The nurse states "i set the rate at 10ml/hr and the volume to be infused at 125ml and hit enter. Somehow the pump infused the cardizem at a rate of 125ml/hr. " he noted that the container was empty after one hr of infusion. He states "i feel the pump must have changed the volume to the rate once i hit enter because i know i remember placing a volume of 125ml and the rate at 10ml/hr. " the pt did not experience any adverse effect from the overdelivery. No further info was available.

 
Manufacturer Narrative

Test and investigation was unable to duplicate the reported problem. The unit passed performance verification testing, short term and long term tests. The observed damaged front panel is not related to the reported event. The frequency of death or serious injury reports for code 102 (overdelivery) for omniflow products is 1. 24/million sets.

 
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Brand NameOMNI-FLOW 4000 PLUS
Type of DeviceINFUSION PUMP
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ABBOTT LABORATORIES
755 jarvis dr.
morgan hill CA 95037
Manufacturer (Section D)
ABBOTT LABORATORIES
755 jarvis dr.
morgan hill CA 95037
Manufacturer (Section G)
HOSPIRA, INC.
755 jarvis dr.
morgan hill CA 95037
Device Event Key108830
MDR Report Key110813
Event Key104189
Report Number2921482-1997-00136
Device Sequence Number1
Product CodeFRN
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 06/27/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/01/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number40051
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/11/1997
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/27/1997
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/01/1993
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Database last updated on February 28, 2009

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