MAUDE Adverse Event Report: ST PAUL REMOTE RESERVOIR ADAPTER(TM) CASSETTE WITH BAG; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7094-24

Device Problems Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182)

Patient Problem Insufficient Information (4580)

Event Date 01/11/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

Information was received a nurse indicating that a pump with cadd administration set tubing was not delivering the correct volume.

• Brand Name: REMOTE RESERVOIR ADAPTER(TM) CASSETTE WITH BAG
• 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: 13496217
• MDR Text Key: 287924065
• Report Number: 3012307300-2022-02982
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586025266
• UDI-Public: 10610586025266
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K933390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2022

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 Operator: Health Professional
• Device Model Number: 21-7094-24
• Device Catalogue Number: 21-7094-24
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2022
• Initial Date FDA Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1