MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD HIGH VOL ADMINISTRATION SET W/FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7346-24

Device Problems Fluid/Blood Leak (1250); Priming Problem (4040)

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

Event Date 10/26/2022

Event Type  malfunction  

Event Description

It was reported that priming the line unsuccessful.It would normally require less then 10 milliliters to prime a line, but this time the pump continued to prime until approximately 20 milliliters.The line was unable to deliver medication as the filter on line was noted to be leaking.No serious harm was reported.There was no patient injury reported.

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 required.Operator of device is unknown.No information has been provided to date.

Manufacturer Narrative

No product or photographic evidence were provided to aid in this investigation.As a result, a complaint investigation / product evaluation and problem confirmation cannot be performed.Lacking any additional evidence in the complaint file attachment, and details in the complaint description, a probable cause could not be determined.Therefore, this complaint has been closed as unconfirmed.If the product is returned, this complaint will be reopened for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).

Manufacturer Narrative

H6: health effects, clinical signs and symptoms or conditions updated, corrected data: h6: evaluation codes conclusion.

• Brand Name: CADD HIGH VOL ADMINISTRATION SET W/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: 15830413
• MDR Text Key: 307515521
• Report Number: 3012307300-2022-27363
• 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,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2023

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: 21-7346-24
• Device Catalogue Number: 21-7346-24
• Device Lot Number: 4248635
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 11/19/2022
• Supplement Dates Manufacturer Received: 03/17/2023; 10/16/2023
• Supplement Dates FDA Received: 06/22/2023; 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1