MAUDE Adverse Event Report: ST PAUL CADD; MS3 SLATE

Model Number 7400

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Fatigue (1849); Diaphoresis (2452)

Event Date 04/07/2021

Event Type  Injury  

Event Description

Information received a smiths medical ambulatory infusion pumps|cadd ms3 pumps under infused as the patient her cassette was still full after 24 hours of infusion.Patient receives: remodulin mdv 5mg/ml, dose or amount: 45.62 ng/kg/min for pulmonary arterial hypertension.She had notified doctor and nurse, she was instructed by them that she should go to hospital if she should become symptomatic and condition worsens.Patient had a back up pump she successfully switched to.However, patient reported to be symptomatic feeling clammy and lousy.Time lapse of under infusion may have contributed to event.Medication is life sustaining.The event was isolated to a pump issue and not cassette.

• Brand Name: CADD
• Type of Device: MS3 SLATE
• 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: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11800954
• MDR Text Key: 249814462
• Report Number: 3012307300-2021-04159
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586029554
• UDI-Public: 10610586029554
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7400
• Device Catalogue Number: 21-7411-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2014
• 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: 58 YR