MAUDE Adverse Event Report: ST PAUL CADD CASSETTE RESERVOIRS - FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7302-24

Device Problem False Alarm (1013)

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

Event Type  malfunction  

Event Description

Information was received indicating that during use of the cadd medication cassette the pump exhibited an unspecified alarm.Per reporter when the cassette was replaced, the alarm resolved.No adverse patient effects were reported.

Manufacturer Narrative

(b)(6).

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Two samples were received in used condition, decontaminated and inside in a plastic bag.The samples were visually inspected at 12 to 16 inches under normal conditions of illumination to detect sample conditions that could cause functional issues.The samples received did not present any damaged, kink, cut or condition that could cause failure mode.During the functional testing the samples were connected, the first sample shows the no disposable alarm at the connection and tries to run.The second sample was connected, and no alarms activated.Complaint was confirmed.The root cause was unable to be determined.A corrective and preventative action was opened to address the reported issue.

• Brand Name: CADD CASSETTE RESERVOIRS - FLOW STOP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-1-1 akasaka,; minneapolis, MN 55442
• MDR Report Key: 14015483
• MDR Text Key: 288613981
• Report Number: 3012307300-2022-05855
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

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: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 04/05/2022
• Supplement Dates Manufacturer Received: 04/26/2023
• Supplement Dates FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female