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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. VITAL SIGNS; INFUSOR, PRESSURE, FOR I.V. BAGS
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VYAIRE MEDICAL, INC. VITAL SIGNS; INFUSOR, PRESSURE, FOR I.V. BAGS Back to Search Results
Catalog Number IN800020
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/24/2020
Event Type  malfunction  
Event Description
Nurse was infusing bolus of normosol-r using carefusion pressure bag.The bulb was pumped to add air pressure to the bag and bag noted to have a slow leak resulting in deflation of the bag, another carefusion pressure bag was obtained and also demonstrated slow leak.
 
Event Description
Nurse was infusing bolus of normosol-r using carefusion pressure bag.The bulb was pumped to add air pressure to the bag and bag noted to have a slow leak resulting in deflation of the bag, another carefusion pressure bag was obtained and also demonstrated slow leak.
 
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Brand Name
VITAL SIGNS
Type of Device
INFUSOR, PRESSURE, FOR I.V. BAGS
Manufacturer (Section D)
VYAIRE MEDICAL, INC.
432-434 industrial ln
birmingham AL 35211
MDR Report Key10670057
MDR Text Key211062260
Report Number10670057
Device Sequence Number1
Product Code KZD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 09/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberIN800020
Device Lot Number180989
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/24/2020
Event Location Hospital
Date Report to Manufacturer10/13/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/13/2020
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age18250 DA
Patient Weight95
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