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

Model Number	2477-0000
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.Patient age and dob requested but not provided.
Event or Problem Description
It was reported that the nurse was disconnecting the blood tubing set after the completion of a blood transfusion when the nurse noticed blood on her glove.Upon assessment the tubing set appeared to be cracked and leaking from the top of the drip chamber.
Additional Manufacturer Narrative
The customer¿s report of cracked and leaking from the top of the drip chamber was confirmed to only be a leak as no cracks were observed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.No anomalies were observed with the set during initial visual inspection.Functional testing found the set leaked at the engagement between the top of the filtered drip chamber and tubing.Closer inspection under a lab microscope observed insufficient solvent at the engagement between the tubing and the top drip chamber ports.A dimensional analysis was performed on the pvc tubing.The tubing was measured and found to be within specification.The root cause of the leak was insufficient solvent at the engagement between the tubing and the top drip chamber ports during manufacturing of the set.
Event or Problem Description
It was reported that the outpatient clinic nurse was disconnecting the blood tubing set after the completion of a blood transfusion when the nurse noticed blood on her glove.Upon assessment the tubing set appeared to be cracked and leaking from the top of the drip chamber.The customer later stated that there were no adverse effects caused to the adult patient from the event.

• 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: 8791720
• Report Number: 9616066-2019-01977
• Device Sequence Number: 19332772
• Product Code: FPA
• UDI-Device Identifier: 07613203011310
• UDI-Public: 7613203011310
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K894842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2019

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: 2477-0000
• Device Catalogue Number: 2477-0000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 11/07/2019
• 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: 06/24/2019