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

Model Number	11484001
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 500 ml eva container, ref: (b)(4), exp: 11/30/2021, therapy date: (b)(6) 2019.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.
Event or Problem Description
It was reported that the nurse responded to the device alarming "air-in-line" to find that the tpn iv bag was empty and that the tubing set had leaked after being in use for approximately 12 hours in the nicu.The infant patient required a new tpn iv bag to be prepared.The customer later stated that there were no adverse effects caused to the patient from the event.
Event or Problem Description
It was reported that the nurse responded to the device alarming "air-in-line" to find that the tpn iv bag was empty and that the tubing set had leaked after being in use for approximately 12 hours in the nicu.The infant patient required a new tpn iv bag to be prepared.The customer later stated that there were no adverse effects caused to the patient from the event.
Additional Manufacturer Narrative
The customer¿s report that the device alarmed for air-in-line and the tubing set leaked was confirmed.Visual inspection of set noted no damage or any anomalies.Functional and pressure testing confirmed leaking from a small hole at the top of the silicone segment near the upper fitment.The source of the air in line alarms and leaks is due to a small hole damage in the silicone pump segment near the upper fitment.The root cause of the hole damage could not be determined.

• 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: 8799111
• Report Number: 9616066-2019-01981
• Device Sequence Number: 2838686
• Product Code: FPA
• UDI-Device Identifier: 10885403232299
• UDI-Public: 10885403232299
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• 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): 06/24/2019

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 Model Number: 11484001
• Device Catalogue Number: 11484001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/09/2019
• 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, THERAPY DATE (B)(6) 2019; 8015,8100, THERAPY DATE (B)(6) 2019
• Patient Age: 8 DA
• Patient Weight: 2