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

Model Number 21-7346-24

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

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

Event Date 05/06/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.No information has been provided to date.

Event Description

It was reported that the cassette under delivered the medication.No patient injury was reported.

Manufacturer Narrative

Other, other text: d5: operator of device: updated.D10: device available for evaluation: updated.H3: device evaluated by manufacturer: updated.H6: event problem and evaluation codes: updated.H10: device evaluation: one sample device was received inside of a plastic bag which is not its original packaging.Visually, the returned unit was inspected at a distance of 12 to 16 inches under normal conditions of illumination according to the procedure.No damages or other defects were detected on the sample.It was observed that the blue clip was not present on the sample.Functionally, the sample was tested for accuracy using a pump device.No discrepancies were detected on the sample, the test successfully passed with a results of 1.528 percent.No bubbles were identified during or after the test was performed thus the failure mode reported is not confirmed.The root cause cannot be determined since the complaint was not confirmed.The root cause cannot be determined since the complaint was not confirmed.No corrective action will be implemented as the complaint was not confirmed.No lot or serial number was provided therefore, a device history record (dhr) review could not be performed.This remediation mdr was generated under protocol b10010579, as a result of warning letter cms# 617147.

• Brand Name: CADD ADMINISTRATION SETS - FLOW STOP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 14th floor, north tower; minneapolis, MN 55442
• MDR Report Key: 14887633
• MDR Text Key: 295138208
• Report Number: 3012307300-2022-12832
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517161953
• UDI-Public: 15019517161953
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

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: Other
• Device Model Number: 21-7346-24
• Device Catalogue Number: 21-7346-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2022
• Initial Date FDA Received: 07/01/2022
• Supplement Dates Manufacturer Received: 01/26/2023
• Supplement Dates FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1