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

Catalog Number 21-7047-24

Device Problems Device Alarm System (1012); Air/Gas in Device (4062)

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

Event Date 03/21/2024

Event Type  malfunction  

Event Description

It was reported that the pump alarmed and the message that was displayed on the screen was "cannot start pump with air in line.Prime tubing." the pump was connected to a patient when the error/event occurred.Continuous infusion rate: 2ml/hr.Total reservoir volume: 3.8ml.Given: 88.2ml.They did not set up for air detector.They were told during in-service that it was on, the same with upstream sensor.Length of infusion: 46 hours.No cstd was used to fill the cassette.The pump was used to prime the extension tubing.Lot number of cassettes or bags: 4415120.The event occurred at the patient's home.No additional details available.The event occurred while in use with the patient.No patient harm/adverse event 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 additional reportable information becomes available.

Manufacturer Narrative

One sample was received for evaluation.Visual and functional testing found no discrepancies.The reported failure mode was 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 ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19145067
• MDR Text Key: 341302905
• Report Number: 3012307300-2024-02853
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586020315
• UDI-Public: (01)10610586020315(17)280923(10)4427216
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2024

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 Catalogue Number: 21-7047-24
• Device Lot Number: 4427216
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/16/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INFUSION PUMP SERIAL NUMBER (B)(6); UNKNOWN ITEM "CASSETTE OR BAG" LOT 4415120