MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD HIGH VOLUME ADMINISTRATION SET WITH FLOWSTOP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7346-24

Device Problem Priming Problem (4040)

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

Event Date 05/29/2023

Event Type  malfunction  

Manufacturer Narrative

A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that, when priming the tubing with medication, the tubing would not prime past the filter, the pump got to 10ml and automatically stopped.It was supposed to prime by 7mll.No patient injury reported.

Manufacturer Narrative

Other, other text: one sample was received for evaluation.Visual inspection found no obstructions, damage, breakage, or other defects detected.To conduct functional testing a priming test was performed.No discrepancies were detected, sample was fully priming and connected without difficulty, the pump was set running, liquid flow through the whole device without interruptions, no alarms were activated, thus, the failure mode reported is not confirmed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: CADD HIGH VOLUME ADMINISTRATION SET WITH FLOWSTOP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17174073
• MDR Text Key: 317634064
• Report Number: 3012307300-2023-06480
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• 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: 4320132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1