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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:; PUMP, INFUSION

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; PUMP, INFUSION Back to Search Results
Model Number 6500
Device Problem Insufficient Flow or Under Infusion (2182)
Patient Problems Cyanosis (1798); Skin Discoloration (2074); Malaise (2359)
Event Date 01/01/2021
Event Type  malfunction  
Manufacturer Narrative
Customer facility phone number: (b)(6).
 
Event Description
Information was received indicating that a smiths medical pump was under delivering medical fluid.The patient's face turned blue and the patient felt sick.No additional medical treatment was needed and the issue was resolved.There were no other reported adverse events.
 
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Type of Device
PUMP, INFUSION
MDR Report Key11455561
MDR Text Key240756750
Report Number3012307300-2021-01857
Device Sequence Number1
Product Code FRN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 03/11/2021
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 No Information
Device Model Number6500
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/08/2021
Initial Date FDA Received03/10/2021
Supplement Dates Manufacturer Received03/10/2021
Supplement Dates FDA Received03/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age55 YR
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