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

Model Number	2207-0007
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
Event or Problem Description
The customer reported that the large volume tubing set (with no inline filter) started to leak below the blue hub and that the silicone pumping segment was spraying tpn.There was no report of patient harm.
Event or Problem Description
The customer reported that the large volume tubing set (with no inline filter) started to leak below the blue hub and that the silicone pumping segment was spraying tpn.Although there was no patient harm, the customer states that changing the tubing set puts the patient at an increased risk of infection.
Additional Manufacturer Narrative
The customer¿s report of set leaked at pump segment was confirmed.During visual inspection of the set received it was noted that the silicone segment had a 0.0712 inch tear near the upper fitment.Microscopic inspection observed no rush marks to the upper blue fitment.Functional testing showed a leak in the same location.The root cause of the customer's report was not identified.
Event or Problem Description
The customer reported that the large volume tubing set (with no inline filter) started to leak below the blue hub and that the silicone pumping segment was spraying tpn.Although there was no patient harm, the customer states that changing the tubing set puts the patient at an increased risk of infection.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8157294
• Report Number: 9616066-2018-02501
• Device Sequence Number: 11195680
• Product Code: FPA
• UDI-Device Identifier: 10885403463952
• UDI-Public: 10885403463952
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2018

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: 11/07/2020
• Device Model Number: 2207-0007
• Device Catalogue Number: 2207-0007
• Device Lot Number: 17116435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 01/02/2019; 01/31/2019
• 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: 8015,8100,BBRAUN PERIFIX FILTER, TD (B)(6) 2018