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

Model Number 21-7361-24

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Type  malfunction  

Event Description

It was reported that the pump using sterile water, plugged to wall outlet, for large volume infusion, primed off the pump both in taper and continuous mode, all of which yielded in pump infusing overfill.No patient injury was reported.

Manufacturer Narrative

Operator of device is unknown.Customer reported to fda is unknown.This mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.No problems or issues were identified during this device history record review.A product sample was received for evaluation.Visual and functional testing were performed.The sample passed the accuracy test.The root cause of the reported issue could not be confirmed as the reported issue could not be replicated at the time of the device evaluation.No actions are required since the complaint was not confirmed.

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16701479
• MDR Text Key: 312887742
• Report Number: 3012307300-2023-03745
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517191738
• UDI-Public: 15019517191738
• 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
• Type of Report: Initial
• Report Date: 04/07/2023

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 Model Number: 21-7361-24
• Device Catalogue Number: 21-7361-24
• Device Lot Number: 4120081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/06/2021
• Initial Date FDA Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1