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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PORTEX; ANESTHESIA CONDUCTION KIT
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PORTEX; ANESTHESIA CONDUCTION KIT Back to Search Results
Device Problem Insufficient Flow or Under Infusion (2182)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2020
Event Type  malfunction  
Event Description
Information was received indicating that the portex kit was used with an ambulatory disposable pump connected to it.The customer checked the remaining amount of medical fluid using a spring balance at a certain time interval.However, it was noted that the medical fluid was not infused as expected.The volume administered did not decrease as expected.There was no patient injury.
 
Manufacturer Narrative
Returned device was received for evaluation.During the evaluation of the device the customer reported condition was confirmed.Problem source was traced to user interface.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
PORTEX
Type of Device
ANESTHESIA CONDUCTION KIT
MDR Report Key11308194
MDR Text Key231183272
Report Number3012307300-2021-01111
Device Sequence Number1
Product Code CAZ
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 03/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2021
Was the Report Sent to FDA? No
Date Manufacturer Received02/23/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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