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

Model Number 21-7349-24

Device Problem Failure to Infuse (2340)

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

Event Date 04/12/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: no product was returned.We are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation.

Event Description

It was reported the set wouldn't infuse.Checked tubing placement in cassette and tried again and infused but then started dripping once infusion had been stopped.Originally came to biomed shop with error of -not infusing- which was confirmed.Tested pump with a known good admin set without issues and pump was within mfg specs.Several pumps are in shop to be tested with the same reported failures.All, so far, have passed without any issues.No patient injury was reported.

• 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): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14349317
• MDR Text Key: 291366352
• Report Number: 3012307300-2022-08441
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517184235
• UDI-Public: 15019517184235
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7349-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1