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

Device Problem Failure to Infuse (2340)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

(2/2 reference (b)(4) for related complaints) (documenting cassette) it was reported that the reservoir volume number had not changed for past 2 hours for the pump.Stated her face was cold, had left sided chest pain, and felt extremely weak and tired.Stated when home, switched to new cassette and pump and remodulin infusing past 15 minutes, reservoir volume number had.Decreased to 97.8 milliliters.And rate 36 milliliters per day.Stated face was feeling warmer but still had chest pain discomfort.Stated she had been in the emergency room this week.For same chest pain but had palpitations and water retention in the stomach area.Stated no palpitations now.Pump serial number (b)(4).Pump replaced.No further details provided.Drug details: drug name, strength and formulation: remodulin 10mg/ml.Manufacturer: united therapeutics dose and route prescribed: remodulin - 120 ng/kg/min - intravenous.Frequency: continuous.Start date: (b)(6) 2020.Lot # 2101981 - expiration date 11/30/2022.Indication/diagnosis for use: primary pulmonary arterial hypertension.

• Brand Name: CADD
• 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; minneapolis, MN 55442
• MDR Report Key: 14591503
• MDR Text Key: 293288472
• Report Number: 3012307300-2022-10593
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 82 KG