MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD MEDICATION CASSETTE RESERVOIR; SET, I.V. FLUID TRANSFER

Model Number 7600

Device Problem Insufficient Flow or Under Infusion (2182)

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

Event Date 07/10/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: the device has not been returned.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 the customer used the cassette with a pump connected to it for a patient who was going through a painless delivery from 7:00 am on (b)(6).At 16:00, the cassette was changed for regular replacement.Medical fluid was administered to the patient until the remaining amount was 3.4 ml.The pump's event log showed that medical fluid was infused normally.However, it looked like almost none was administered.So the customer suspected an under deliver occurred in the cassette.No patient injury was reported.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2022-14873.The report was submitted in error., corrected data: corrected information provided in h10.

• Brand Name: CADD MEDICATION CASSETTE RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• 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; 7-15-26 fukushima,; minneapolis, MN 55442
• MDR Report Key: 15176793
• MDR Text Key: 304962820
• Report Number: 3012307300-2022-14873
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 10610586044007
• UDI-Public: 10610586044007
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K162219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2023

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: 7600
• Device Catalogue Number: 21-7600-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 08/05/2022
• Supplement Dates Manufacturer Received: 05/11/2023
• Supplement Dates FDA Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1