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

Model Number 21-7302-24

Device Problem False Alarm (1013)

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

Event Date 02/24/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

Information was received indicating that during use of a cadd medication cassette on a cadd-legacy plus pump, the pump exhibited a "no disposable, pump won't run" alarm.It was reported that the cassette was removed and reattached and the alarm persisted.Per reporter the cassette was then tried on a different pump with no success.It was reported that when a new cassette was placed, the alarm was cleared.No adverse patient effects were reported.

Manufacturer Narrative

Other text: h6: event problem and evaluation codes: updated.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Samples received: sample received consist in one (1) cassette product from part number 21-7302-24.Sample was received in used conditions, decontaminated and inside in a plastic bag.Visual inspection: 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.Results: sample received don?t present any damaged, kink, cut.Sample was received without blue clip and with red cap assembled.Functional testing: sample was filled with 100 ml of water; the sample was connected to the cadd legacy plus [cal.Id; 1.0130 due date: august 2022] to look for unusual function.Results: sample was fully priming and connected without difficult, the pump was set running and no alarms were activated.Complaint is not confirmed.The cause of the reported problem could not be determined.

• Brand Name: CADD MEDICATION CASSETTE
• 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: 14014893
• MDR Text Key: 288615315
• Report Number: 3012307300-2022-05843
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2022
• 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: 77 YR
• Patient Sex: Female