MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD ADMINISTRATION SETS - FLOW STOP; SET, ADMISTRATION, INTRVASCULAR

Model Number 7346

Device Problems Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Improper Flow or Infusion (2954)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2021

Event Type  malfunction  

Event Description

Information was received indicating that during use of this smiths medical cadd administration sets, under delivery was noticed.It was reported that pump was supposed to be infused 2000ml over 24 hours, but 600 ml was left in the bag.The pump indicated that 2,000 ml was infused.Reported that the patient did not receive the full quantity of drug prescribed.No patient injury reported.

Event Description

Information was received indicating that during use of this smiths medical cadd solis vip pump, under delivery was noticed.It was reported that pump was supposed to infuse 750 ml over 24 hours.The pump showed 750 ml was infused but 240 ml was left in bag.Reported that the patient did not receive the full quantity of drug prescribed.No patient injury reported.

Manufacturer Narrative

This mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.

• Brand Name: CADD ADMINISTRATION SETS - FLOW STOP
• Type of Device: SET, ADMISTRATION, INTRVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; acb8.2030, unit 1280; minneapolis, MN 55442
• MDR Report Key: 11721668
• MDR Text Key: 247209156
• Report Number: 3012307300-2021-03446
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517161953
• UDI-Public: 15019517161953
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2023

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: 7346
• Device Catalogue Number: 21-7346-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/24/2021
• Supplement Dates Manufacturer Received: 04/23/2021; 02/09/2023
• Supplement Dates FDA Received: 05/23/2021; 02/21/2023
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1