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

Model Number 21-7301-24

Device Problem Device Alarm System (1012)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pallor (2468)

Event Date 02/12/2021

Event Type  malfunction  

Event Description

Information was received indicating that a pump with a cadd medication cassette attached was alarming "cassette disconnected".It was reported the end user stated his hemodynamic variables changed, paleness and low blood pressure.

Manufacturer Narrative

Report source: (b)(6).

Manufacturer Narrative

Other, other text: , corrected data: event date added (updated b3).

Manufacturer Narrative

Device evaluation: one (1) photo was received and reviewed.The photo showed a cassette connected to a pump with the pump displaying a "cassette disconnected" message.Four (4) samples were received with item number 21-7301-24 in used condition without original packaging, decontaminated inside a plastic bag.Visual inspection showed no discrepancies.Functional testing involved filling the sample with water and connecting it to a cadd legacy plus pump to look for unusual function.The sample was fully primed, connected with no difficulties and no alarms occurred when pump was running.Based on the investigation, the complaint allegation was not confirmed.There is not non-conformance or deviation related to the failure reported in the device history record for finish good and component associated.

• 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; ofc 518; minneapolis, MN 55442
• MDR Report Key: 13260535
• MDR Text Key: 284304669
• Report Number: 3012307300-2022-00783
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027215
• UDI-Public: 10610586027215
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 21-7301-24
• Device Catalogue Number: 21-7301-24
• Device Lot Number: 4114179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Ethnicity: Hispanic