MAUDE Adverse Event Report: UNKNOWN PUMP; PUMP, INFUSION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Pulmonary Edema (2020); Low Oxygen Saturation (2477)

Event Type  Injury  

Event Description

Per communication from (b)(6): adverse events experienced: decreased oxygenation, fatigue, pulmonary edema.Description of event: (b)(6) rn with md office informed cnss that patient has continued to deteriorate while on remunity while titrating in hospital, reaching a total of 48 ng/kg/min.Per echocardiogram, patient was shunting and experienced flash pulmonary edema, continuing to require high amounts of oxygen.Medical team has decided to transition him to iv remodulin at this time so they can stabilize him.Remunity discontinued at 10:15am on (b)(6) 2023.Adverse event start date: (b)(6)2023.Sub-q remunity self-fill patient prior to discontinuation.No further information known including hospital admit date or anticipated discharge date.Length of stay is ongoing.Reported to (b)(6) by: health professional.

• Brand Name: PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 16296026
• MDR Text Key: 308914741
• Report Number: MW5114677
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: NAME: AMBRISENTAN.STRENGTH: 10MG.MANUFACTURER: CIPLA USA.
• Patient Outcome(s): Hospitalization
• Patient Sex: Male