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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL; SET, ADMINISTRATION, INTRAVASCULAR
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NULL; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Inaccurate Delivery (2339)
Patient Problem Low Blood Pressure/ Hypotension (1914)
Event Date 04/01/2023
Event Type  malfunction  
Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
 
Event Description
It was reported while using the disposable extension set the patient is new to remodulin this admission and are getting severe hypotension requiring pressors to support them.They have their remodulin doses titrated down and weaned off pressors.To resolve symptoms, required treatment included added pressors, moved to icu, profound hypertension (symptoms are not uncommon, but are not this severe.
 
Manufacturer Narrative
Other, other text: no product was returned.We are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation.No serial/lot number was provided; therefore, a device history record (dhr) review could not be conducted.
 
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Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section G)
NULL
MDR Report Key16776974
MDR Text Key313655901
Report Number3012307300-2023-04335
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/30/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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