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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. CADD; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7363-24
Device Problems Device Alarm System (1012); Infusion or Flow Problem (2964)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Information was received that during use of this smiths medical cadd administration sets, the pump exhibited sporadic air alarms.No adverse effects were reported.
 
Manufacturer Narrative
Returned device was received for evaluation.During the evaluation of the device the customer reported condition was not confirmed, no difficulty were detected during the priming and no alarms were activated, also no air bubbles were found in any of the samples tested; thus the failure mode reported is not confirmed.No fault found.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
 
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Brand Name
CADD
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key11205249
MDR Text Key227919376
Report Number3012307300-2021-00602
Device Sequence Number1
Product Code FPA
UDI-Device Identifier15019517161960
UDI-Public15019517161960
Combination Product (y/n)N
PMA/PMN Number
K031361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 05/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number21-7363-24
Device Catalogue Number21-7363-24
Device Lot Number4025977
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2021
Was the Report Sent to FDA? No
Date Manufacturer Received05/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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