MAUDE Adverse Event Report: SMITHS MEDICAL ASD,INC CADD MS3 GRAY SLATE; PUMP, INFUSION

Model Number 7400

Device Problems Infusion or Flow Problem (2964); Complete Loss of Power (4015)

Patient Problem Respiratory Distress (2045)

Event Date 10/30/2019

Event Type  Injury  

Event Description

Information received a smiths medical cadd ms3 gray slate pump stopped in the middle of the night during infusion of drug that is life sustaining for diagnoses of pulmonary arterial hypertension.Drug remodulin 37.4ng/kg/min, frequency: continuous therapy was interrupted.The consumer of the pump was experiencing some shortness of breath and was able to switch to a functional back up pump.Airway compromise can become life threatening if interventions are not implemented to control breathing.No further airway interventions were reported other then feeling short of breath and requiring medication to aide in flow of blood from pulmonary arteries to systemic circulation.

• Brand Name: CADD MS3 GRAY SLATE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD,INC; 6000 lane n; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD,INC; 6000 lane n; minneapolis MN 55442
• Manufacturer Contact: dave halverson ; 6000 lane n; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 9398911
• MDR Text Key: 168811791
• Report Number: 3012307300-2019-06698
• 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: consumer,distributor,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 7400
• Device Catalogue Number: 21-7411-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2016
• 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 Outcome(s): Other
• Patient Age: 78 YR