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

Model Number	21-7061-24
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that during use of this smiths medical cadd cassette reservoirs, over deliver of medical fluid was observed.It was reported that the customer estimated some amount of medical fluid was supposed to remain in the cassette; however, none was found in it.No patient injury reported.
Additional Manufacturer Narrative
Other text: a sample was received to perform an investigation.Functional testing was performed using a leak test, and no leak was detected.In addition, accuracy testing was performed, and the sample passed the accuracy test.A device history record (dhr) review could not be performed as the lot number was unknown.No root cause could be determined as the complaint could not be confirmed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Corrected data: correction h5.

• Brand Name: CADD EXTENSION SETS
• Common Device Name: 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: david halverson ; 6000 nathan lane north; 2-12-12 kitanagase-omotemachi,; minneapolis, MN 55442
• MDR Report Key: 11775056
• Report Number: 3012307300-2021-03815
• Device Sequence Number: 3535718
• Product Code: FPA
• UDI-Device Identifier: 10610586020445
• UDI-Public: 10610586020445
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K942046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2022

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
• Operator of Device: Health Professional
• Device Model Number: 21-7061-24
• Device Catalogue Number: 21-7061-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 07/03/2022
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Race: Asian