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 03/01/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Information was received indicating that during use of the cassette on a cadd-legacy plus pump , the pump indicated "run" on the display, but an alarm kept sounding and "it would not allow the customer to stop the operation." it was reported that the cassette was subsequently changed to a different pump, but the issue continued.Per reporter when a new cassette was used, the alarm cleared.It was reported that the alarm displayed may have been "no message." no adverse patient effects were reported.

Manufacturer Narrative

Other, other text: device evaluation: one device was returned for analysis in used condition.Visual inspection showed no discrepancies.Functional testing involved filling the device with water and connecting it to a cadd legacy plus pump to look for unusual function.The sample was fully primed and connected without difficulty.When the pump was set to running, the pump exhibited a "no disposable" alarm.Based on evidence and investigation, the complaint allegation was confirmed.There is no non-conformance or deviation related to the failure reported in the device history record for finished good and associated component.

• 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): ST PAUL; 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: 14043108
• MDR Text Key: 288792795
• Report Number: 3012307300-2022-05953
• 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: 06/22/2022

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 Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 4163622
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/15/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 04/07/2022
• Supplement Dates Manufacturer Received: 05/30/2022
• Supplement Dates FDA Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Sex: Female