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

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.

• Brand Name: PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VA
• Type of Device: SET, 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 Key: 13471183
• MDR Text Key: 285161961
• Report Number: 3012307300-2022-02766
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586020315
• UDI-Public: 10610586020315
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2022

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 Model Number: 21-7047-24
• Device Catalogue Number: 21-7047-24
• Device Lot Number: 4142893
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/21/2022
• Initial Date FDA Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1