MAUDE Adverse Event Report: UNKNOWN; TUBING, IV ADMINISTRATION SET

Device Problems Air Leak (1008); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/20/2016

Event Type  malfunction  

Event Description

Iv pump alarming "air leak." multiple air bubbles throughout tubing.Cannot define cause.Did not reach patient.

• Type of Device: TUBING, IV ADMINISTRATION SET
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 6630046
• MDR Text Key: 77218716
• Report Number: 6630046
• 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: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/02/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NO OTHER THERAPIES