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

Model Number	10013037
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2019
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
It was reported that there was leaking from right above the drip chamber.The patient received the unit of blood when it was noticed.There was no patient harm.
Event or Problem Description
It was reported that there was leaking from right above the drip chamber.The patient received the unit of blood when it was noticed.There was no patient harm.
Additional Manufacturer Narrative
The customer report of leaking from above the drip chamber was confirmed.Visual inspection of the as-received sample observed dried blood residue atop the blood filter drip chamber.The set was attempted to be reprimed in which further inspection observed fluid to leak out from both tubing engagements to their corresponding inlet ports on the top of the blood filter drip chamber component.Further inspection of the leaking engagements observed areas of the outer wall of the tubing not fully adhered against the inner wall of the blood filter drip chamber inlet port.Dimensional analysis of the tubing was measured to be within specification which points to the root cause of insufficient solvent being applied at the engagement of the tubing ends.The root cause of the leak was identified to be a result of incorrect bonding method into dispenser and flow restrictions that didn¿t apply a sufficient amount of solvent needed to facilitate full tubing insertion into the drip chamber cap.

• 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: 8891272
• Report Number: 9616066-2019-02247
• Device Sequence Number: 2534135
• Product Code: FPA
• UDI-Device Identifier: 10885403233784
• UDI-Public: 10885403233784
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K894842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2019

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: 10013037
• Device Catalogue Number: 10013037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 82