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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS® GRAVITY ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION ALARIS® GRAVITY ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number CS42522E-07
Device Problem Disconnection (1171)
Patient Problems Awareness during Anaesthesia (1707); Therapeutic Effects, Unexpected (2099)
Event Type  Injury  
Manufacturer Narrative
No product returned.Because no product was returned or expected to be returned, no failure investigation could be performed.The root cause of the customer's experience was not identified.
 
Event Description
It was reported that a patient woke up during surgery.The anesthesiologist did not realize the tubing had disconnected and the anesthetizing medication was not going to the patient.The medication was draining on the floor.The tubing was reconnected and the patient was given additional medication and placed back under anesthesia.
 
Manufacturer Narrative
Supplemental created to change to serious injury.
 
Event Description
It was reported that a patient woke up during surgery.The anesthesiologist did not realize the tubing had disconnected and the anesthetizing medication was not going to the patient.The medication was draining on the floor.The tubing was reconnected and the patient was given additional medication and placed back under anesthesia.
 
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Brand Name
ALARIS® GRAVITY ADMINISTRATION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key9305841
MDR Text Key190495300
Report Number9616066-2019-03195
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K960280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 10/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCS42522E-07
Device Catalogue NumberCS42522E-07
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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