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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNK SET, ADMINISTRATION, INTRAVASCULAR

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UNK SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Defective Device (2588)
Patient Problems Dyspnea (1816); Swelling/ Edema (4577)
Event Date 08/08/2021
Event Type  Injury  
Event Description
Patient stated had site change & pump change (b)(6) 2021 & had blood in tubing. (b)(6) 2021 pt woke up and the blood was gone from the tubing & there was no alarm. However, her normal pain she gets from infusion was completely gone. (b)(6) 2021 patient experienced worsening in breathing. Pt saw md & was told that pulmonary pressure was high but they could not help her with the pump or tubing. However, they gave her diuretics to help with her swelling. Per pt, she rotated the pump yesterday & changed to a new site yesterday and had no issues since then with her pump & tubing. It seems that she is getting the medication now & breathing is better than before. Patient not sure if the issue was with pump serial number (b)(4) and it just did not deliver drug & did not alarm or something else. Sending new pump for malfunction. Did the reported product fault occur while in use with the patient? yes. Did the product issue cause or contribute to pt or clinical injury? yes. Swelling and difficulty breathing, was any medical intervention provided? yes. Mc provided pt with diuretic. Is the actual device available for investigation? yes. Device serial number is (b)(4). Did we replace the device? yes. Did the pt have a backup device they were able to switch to? yes. If yes, was the pt able to successfully continue their infusion? yes. Is the infusion life-sustaining? yes. What is the outcome of the event? resolved. No other info provided at this time. Reported to (b)(6) pt/caregiver.
 
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Brand NameSET, ADMINISTRATION, INTRAVASCULAR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
UNK
unk MN
MDR Report Key12331581
MDR Text Key267242634
Report NumberMW5103278
Device Sequence Number2
Product Code FPA
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/12/2021
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received08/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

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