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

Model Number 11532269

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Positioning Problem (3009)

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

Event Date 07/13/2020

Event Type  malfunction  

Event Description

The iv tubing was not able to be primed due to faulty manufacturing.First access port (access site directly below pump chamber) is downward instead of necessary upward position.Medication could not be primed past the first access port.

• Brand Name: ALARIS PUMP MODULE SMARTSITE LOW SORBING 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: 10641651
• MDR Text Key: 210230278
• Report Number: 10641651
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11532269
• Device Catalogue Number: 10885403232343
• Device Lot Number: 20056497
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2020
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1