MAUDE Adverse Event Report: ST PAUL CADD ADMINISTRATION SET WITH FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7394-24

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Vomiting (2144); Dizziness (2194); Lethargy (2560)

Event Date 01/23/2023

Event Type  Death  

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 while a smiths medical pump was being used with the patient, the patient experienced dizziness, lethargy and vomiting.The patient's family called 911 and the patient was taken to the hospital where it was found that the medication bag was empty.Customer states the bag was not supposed to be empty until the next day.The patient was admitted to the hospital and expired three days later.The customer tested the pump and they determined that the bag and tubing had 12.75ml even though the pump read that there was 58ml left.

Manufacturer Narrative

Other, other text: confirmed that there has any damage to the disposable (it was noted upon return that there was no clamp on the tubing).The bag confirmed to have been filled to 500 ml.It was manually primed in the clean room, no, the priming volume was not noted.Customer cannot confirm if the bag under pressure during the infusion or significantly higher than the patient.And was used of the same set for 7 days prescribed by the hcp.

Manufacturer Narrative

One sample was received for evaluation.Visual inspection revealed the sample was received undamaged; however, it was observed that sample returned with a clamp that did not belong to the device, additionally it was observed that the sample had remained liquids in the fluid path.Functional testing was unable to be performed due to being clogged due to liquid remaining in the fluid path.The root cause was unable to be determined.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.For all enquiries or follow-up questions related to the record, do not use regulatory.Responses@smiths-medical.Com located in sections g.1., please direct those to the following: (b)(6).

• Brand Name: CADD ADMINISTRATION SET WITH FLOW STOP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16368327
• MDR Text Key: 309460634
• Report Number: 3012307300-2023-01206
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027536
• UDI-Public: 10610586027536
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040636
• 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: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7394-24
• Device Catalogue Number: 21-7394-24
• Device Lot Number: 4339177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Death; Required Intervention