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

Model Number 21-7363-24

Device Problems Filling Problem (1233); Insufficient Flow or Under Infusion (2182)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2022

Event Type  malfunction  

Manufacturer Narrative

Report source: (b)(6).

Event Description

Information was received indicating that a pump with a cadd administration set attached was slow and intermittently pre-filling, the filter was reported to be completely full and ran empty again for approximately 45 minutes.It was reported the filter had to be held vertically while infusing to fill the filter and that air could only be removed temporarily which required the batch to be changed.Per reporter a different lot was used with no issues over a two day period.

Event Description

Additional information was received that no patient injury occurred.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Samples received: 11 samples were returned for evaluation, one sample came without its original packaging in used condition, decontaminated and inside a plastic bag.10 samples were returned in unused conditions within its original sealed packaging.Visual inspection: the complainant returned units were visually inspected at a distance of 12 to 16 inches under normal conditions of illumination, per visual inspection, no damages or other discrepancies were detected.Functional testing: in the 10 unused samples, air was completely purged, and the water flowed easily through the entire unit, no leakage, occlusion or air collection in the filter was observed.In the used sample, air was completely purged, and the water flowed easily through the entire unit, however it started to leak from the air vent in the filter.Root cause: no root cause could be related to the manufacturing process, it was determined as a supplier component issue.Action taken: a supplier corrective action report (scar) was communicated to the supplier on jul 2021 and closed in december 2021.

• Brand Name: CADD ADMINISTRATION SET
• 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: 13391812
• MDR Text Key: 284687193
• Report Number: 3012307300-2022-02158
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517161960
• UDI-Public: 15019517161960
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2023

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: 21-7363-24
• Device Catalogue Number: 21-7363-24
• Device Lot Number: 4185839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2022
• Initial Date FDA Received: 01/31/2022
• Supplement Dates Manufacturer Received: 05/02/2023
• Supplement Dates FDA Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1