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

Model Number	41173E
Medical Device Problem Codes	Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.Although requested, the patient's demographics was not provided.
Event or Problem Description
It was reported that set would not infuse.No patient harm.
Event or Problem Description
It was reported that set would not infuse.No patient harm.
Additional Manufacturer Narrative
The customer¿s report that the set would not infuse was not confirmed.Visual inspection of the set noted no damage or any anomalies.Functional and pressure testing resulted in the set flowing freely and showed no signs of occluding.The set was then setup for a gravity infusion using the attached infusion bag.The infusion was setup for a rate of 75ml/h and 75ml vtbi.The infusion completed successfully with no occlusions or difficulties occurring.The root cause of the customer¿s report was not determined.

• Brand Name: ALARIS GRAVITY SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8884765
• Report Number: 9616066-2019-02226
• Device Sequence Number: 2494799
• Product Code: FPA
• UDI-Device Identifier: 07613203020893
• UDI-Public: 7613203020893
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/23/2022
• Device Model Number: 41173E
• Device Catalogue Number: 41173E
• Device Lot Number: 19046694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 08/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 250ML BAXTER BAG, THERAPY DATE (B)(6) 2019; 250ML BAXTER BAG, THERAPY DATE (B)(6) 2019