MAUDE Adverse Event Report: CAREFUSION 303, INC. ALARIS PUMP MODULE INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 10942011

Device Problems Crack (1135); Failure to Infuse (2340)

Patient Problem Insufficient Information (4580)

Event Date 06/26/2022

Event Type  malfunction  

Event Description

Crack in portless iv tubing so oxytocin not infusing into patient.Dripping caught by patient and nurse and nurse replaced tubing.

• Brand Name: ALARIS PUMP MODULE INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 14955970
• MDR Text Key: 295490892
• Report Number: 14955970
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10942011
• Device Catalogue Number: 10942011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/27/2022
• Date Report to Manufacturer: 07/08/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 8030 DA
• Patient Sex: Female
• Patient Weight: 72 KG