MAUDE Adverse Event Report: NULL; PUMP, INFUSION

Device Problems Device Alarm System (1012); Patient Device Interaction Problem (4001)

Patient Problem Respiratory Failure (2484)

Event Date 02/03/2021

Event Type  Injury  

Event Description

It was reported that a smiths medical pump alarms for both user's pumps that cannot be restarted resulting in breathing problems requiring hospitalization.No further adverse patient effects were reported.

• Type of Device: PUMP, INFUSION
• Manufacturer (Section G): NULL
• MDR Report Key: 11458089
• MDR Text Key: 239073659
• Report Number: 3012307300-2021-01899
• 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: Other
• Type of Report: Initial
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2021
• 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 Outcome(s): Hospitalization
• Patient Age: 34 YR