MAUDE Adverse Event Report: ST PAUL CADD; MS3

Device Problem Device Alarm System (1012)

Patient Problems Hypoxia (1918); Seizures (2063)

Event Date 06/01/2020

Event Type  Injury  

Event Description

Information received a smiths medical pump caused malfunction.Reported per medwatach : remodulin order, per the patient, she is in the hospital and has been for 2 days.I am not sure why, patient was very difficult to understand.Patient also mentioned one of her pumps is not working.She does not know what the error message was nor does she know the serial number.No harm to the patient; pump is not in use and not the cause of the hospitalization - it was not working before then.Patient is still reported in the hospital.Back up pump was available but not in use do to the patient hospitalized and reported seizure.Medication remodulin mdv.Strength: 5mg/ml.Dose or amount: 13.3ng/kg/min.Frequency: continuous.Route: subcutaneous.Dates of use: from (b)(6) 2019 to current.Diagnosis or reason for use: pah.This event may have been caused from malfunction of the pump, as when pulmonary arterial hypertension not controlled, may contribute to hypoxia as the pulmonary arteries would become constricted leading to hypoxia, which in turn may lead to seizure.No further information provided other then was revealed on the medwatch form.

• Brand Name: CADD
• Type of Device: MS3
• 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; 9th floor ste 945; minneapolis, MN 55442
• MDR Report Key: 10361974
• MDR Text Key: 201673764
• Report Number: 3012307300-2020-07765
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR