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

Model Number 21-7302-24

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 02/21/2022

Event Type  malfunction  

Manufacturer Narrative

Other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Visual and functional tests were performed.Sample received consists in one (1) cassette product.A sample was received in used conditions without its original packaging, decontaminated and inside in a plastic bag.The sample was visually inspected at a distance of 12? to 16? under normal conditions of illumination to detect sample conditions that could cause functional issues.The sample received did not present any damaged, kink, cut or condition that could cause failure mode.The pump tube height fails; however due sample was received in used conditions it is possible that the pump tube height was modified during the use.The sample failed the accuracy test.The sample was fully priming and connected without difficulty, the pump was set running and no alarms were activated.The reported issue was not confirmed.The root cause was undetermined.Actions taken were not performed due complaint was not confirmed.

Event Description

It was reported that the customer changed the cassette for a regular replacement.A "no disposable, pump won't run" alarm went off, so the patient changed the pump to another one.However, the alarm persisted.Patient then changed the cassette to another one.After that, the alarm was cleared, and the system got back to working normally.No patient injury was reported.

• 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): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16875398
• MDR Text Key: 314624218
• Report Number: 3012307300-2023-05137
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• 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: 03/31/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Female