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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYGON COLOMBIA S.A 60¿ ULTRA-MICROBORE EXTENSION SET WITH MALE/FEMALE LUER; TUBING, FLUID DELIVERY
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VYGON COLOMBIA S.A 60¿ ULTRA-MICROBORE EXTENSION SET WITH MALE/FEMALE LUER; TUBING, FLUID DELIVERY Back to Search Results
Catalog Number AMS-747
Device Problems Kinked (1339); Improper Flow or Infusion (2954)
Patient Problem Hematoma (1884)
Event Date 05/16/2016
Event Type  Injury  
Event Description
Two week old infant born at (b)(6) gestation.Likely septic on dopamine for hypotension.The tubing for the dopamine was kinked in an incubator door, so that there was very little dopamine flowing and the blood pressure drifted downward, and clinical team kept increasing the dose of dopamine with no effect until the kinked tubing was found and after opening that tubing the blood pressure went up to 60 rapidly.Everything was turned off, and over the course of an hour the mean pressure came down to 40.This resulted in a parafalcine subdural hematoma.
 
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Brand Name
60¿ ULTRA-MICROBORE EXTENSION SET WITH MALE/FEMALE LUER
Type of Device
TUBING, FLUID DELIVERY
Manufacturer (Section D)
VYGON COLOMBIA S.A
2750 morris rd suite a200
lansdale, PA 19446
MDR Report Key5842723
MDR Text Key51021356
Report Number5842723
Device Sequence Number0
Product Code FPA
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 07/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2016
Is this an Adverse Event Report? Yes
Device Operator No Information
Device Catalogue NumberAMS-747
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/21/2016
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer07/21/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
OMNI-GIRAFFE ISOLETTE¿ MANUFACTURER: OHMEDA MEDI
Patient Outcome(s) Life Threatening;
Patient Weight1
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