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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VA SET, ADMINISTRATION, INTRAVASCULAR

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ST PAUL PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VA SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7047-24
Device Problems Device Alarm System (1012); Excess Flow or Over-Infusion (1311)
Patient Problems Nausea (1970); Vomiting (2144); Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Information was received indicating that a pump with cadd extension set attached alarmed no cassette when the infusion was completed, and the cassette was completely empty. It was reported the pump was scheduled to infuse until 13:00 but completed at 07:30. Per reporter the end user reported nausea and vomiting during the night.
 
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Brand NamePHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VA
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key13471183
MDR Text Key285161961
Report Number3012307300-2022-02766
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586020315
UDI-Public10610586020315
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K942046
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number21-7047-24
Device Catalogue Number21-7047-24
Device Lot Number4142893
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/07/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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