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

Model Number 21-7364-24

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 10/19/2022

Event Type  malfunction  

Event Description

It was reported that the device over delivered the medication.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.

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

Other text: h6: event problem and evaluation codes: updated.H10: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Three product samples were received for evaluation.Visual and functional testing was performed.Visual inspection found no visually discrepancies were detected.Functional testing of pump tube height: the samples were tested to measure the height of the pump tube arch and determine if is under or out of spec.The samples failed the arch height tube measure; green color is an ?ok? tube arch is under spec, red color is an ?ng? tube arch is out of spec.The pump tube height was sample one 0.1679in, sample two 0.1377in and sample three 0.1949 in.The root cause of the reported issue was found to be manufacturing - based on the internal capa, root cause for the following containment action was performed: allow for assembly work orders in disposables lines using as primary component ? arm, occlusion, minimum in flow stop codes was issued on 17-oct-2022.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: CADD ADMINISTRATION SETS WITH FLOW STOP
• Type of Device: 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15748203
• MDR Text Key: 307197530
• Report Number: 3012307300-2022-26836
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517191776
• UDI-Public: 15019517191776
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

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: Lay User/Patient
• Device Model Number: 21-7364-24
• Device Catalogue Number: 21-7364-24
• Device Lot Number: 4279907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2022
• Initial Date FDA Received: 11/07/2022
• Supplement Dates Manufacturer Received: 04/06/2023
• Supplement Dates FDA Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1