MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 11607704

Device Problem Occlusion Within Device (1423)

Patient Problem No Code Available (3191)

Event Date 02/15/2018

Event Type  Injury  

Manufacturer Narrative

The affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.

Event Description

Received a copy of the customer's sus voluntary event report from fda, which states ¿over the past few weeks, we have had numerous staff report difficulties while attempting to prime the smartsite infusion set primary iv tubing; this product malfunction has been replicated across numerous units with multiple types of fluids." the customer's medwatch report lists product problem and the event description does not indicate any patient involvement, but "hospitalization" is checked in outcomes attributed to adverse events.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 7429430
• MDR Text Key: 105423771
• Report Number: 9616066-2018-00406
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11607704
• Device Catalogue Number: 11607704
• Other Device ID Number: 10885403228001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization