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Adverse Event Report

3M CO. SARNS BLOOD PUMP   back to search results
Model Number 5000
Patient Outcome  Required Intervention;
Event Description

During a bypass procedure, there was no electricity going to the bypass pump machine. The cords were put in another electrical outlet. During that interval, the pump was on back-up battery. Biomed, maintenance, and the charge nurse were notified. Machine was taken out of circulation for testing. Possible cause was heaters/coolers were plugged into the same 20 amp circuit. The combined draw is 27 amps, tripping the circuit breaker.

 
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Brand NameSARNS
Type of DeviceBLOOD PUMP
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
3M CO.
3m center, bldg 275-3e-08
st. paul MN 55133 3275
Device Event Key248457
MDR Report Key256575
Event Key240473
Report NumberMW1017782
Device Sequence Number1
Product CodeDWB
Report Source Voluntary
Report Date 12/14/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/22/1999
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number5000
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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