MAUDE Adverse Event Report: ST PAUL CADD MEDICATION CASSETTES; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7302-24

Device Problem Use of Device Problem (1670)

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

Event Date 03/06/2022

Event Type  malfunction  

Event Description

It was reported that infusion pump/medical reservoir cassette failures occurred.No patient injury was reported.

Manufacturer Narrative

No product or photographic evidence were provided to aid in this investigation.The complaint report offered insufficient details to determine whether this product functioned as intended, or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.If the product is returned, smiths medical will reopen this complaint for further investigation.A manufacturing dhr review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.

Manufacturer Narrative

This remediation mdr was generated under protocol b10010116, as a result of warning letter cms#617147., corrected data: device history review:no problems or issues were identified during this device history review.

• Brand Name: CADD MEDICATION CASSETTES
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14283033
• MDR Text Key: 290796165
• Report Number: 3012307300-2022-07536
• Device Sequence Number: 1
• Product Code: FPA
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 4235218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female