MAUDE Adverse Event Report: NULL; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Failure to Prime (1492); Priming Problem (4040)

Patient Problem Loss of consciousness (2418)

Event Date 04/11/2023

Event Type  malfunction  

Manufacturer Narrative

A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that after the previously reported double pump malfunction that the patient did pass out and is currently admitted to the hospital and doing better now.The patient's mother also reports that when patient was trying to trouble shoot the double pump malfunction, the tubing was not priming.Tubing was not in use when fault occurred, patient was trying to prime it.Patient's mother reports patient experienced some lapse in epoprostenol infusion and side effects or clinical injury due to previously reported double pump malfunction passed out.No additional info, details, or dates available.This is a continuous infusion.The position of the pump when the alarm occurred is not applicable as no pump issue reported.Pump return tracking information is not applicable as no pump issue reported.The reported product did not fault occurs while in use with the patient.The product issue didn't cause or contribute to patient or clinical injury.Medical intervention was provided.Patient hospitalized.

Manufacturer Narrative

It has been determined that complaint file cc-0194470 with a manufacturing report number of 3012307300-2023-04987 is a duplicate complaint entered in error.Please disregard the previous submission(s).Any additional reporting will be conducted under the applicable file.

• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section G): NULL
• MDR Report Key: 16862382
• MDR Text Key: 314483834
• Report Number: 3012307300-2023-04987
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2023
• 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
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Sex: Female