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	02/25/2020
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.Patient demographics requested but not provided, however the customer stated that the patient was a neonate patient.
Event or Problem Description
It was reported that the tubing set leaked at the filter during a tpn infusion infusing via the patient's picc line.The customer further stated that the "filter appeared to be tightly attached to tpn fluid line but the line seemed loose above where the filter screwed in." there were no adverse effects to the neonate patient.
Additional Manufacturer Narrative
The customer¿s report that the tubing set leaked at the filter was not confirmed.No anomalies were observed with the received set during visual inspection.Functional testing showed no anomalies.The root cause of the customer¿s report could not be identified because no leaks occurred with the received set.Device history record for model 2207-0007 could not be performed due to no lot number being provided by customer.
Event or Problem Description
It was reported that the tubing set leaked at the filter during a tpn infusion infusing via the patient's picc line.The customer further stated that the "filter appeared to be tightly attached to tpn fluid line but the line seemed loose above where the filter screwed in." there were no adverse effects to the neonate patient.

• 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: 9926093
• Report Number: 9616066-2020-01179
• Device Sequence Number: 2320138
• 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: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2020

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: 2207-0007
• Device Catalogue Number: 2207-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2020
• Supplement Report FDA Received Date: 07/03/2020
• 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: B BRAUN CONNECTOR, TD (B)(6) 2020