MAUDE Adverse Event Report: CAREFUSION ALARIS PCA MICROBORE SET; SET, EXTENSION, INTRAVASCULAR

Model Number	30853
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a patient was on a pca pump.The physician's assistant notified the rn that the pca pump tubing was leaking onto the floor.The rn assessed the tubing line and found that there was a small leak in the tubing.The tubing was removed.There was no delay, patient harm or death reported.
Additional Manufacturer Narrative
The customer¿s report that there was a small leak in the tubing was confirmed due to a slice/cut in the tubing.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection observed a cut/slice on the tubing on the proximal tubing below the anti-siphon.The cut extended almost completely across the tubing.Liquid leaked from the cut that extended diagonally almost completely across the tubing.No other damages or anomalies were observed throughout the set.Functional testing was performed and the set leaked from the tubing cut that was observed during visual inspection.No other leaks were observed throughout the set.The root cause of the cut was not identified.
Event or Problem Description
It was reported that a patient was on a pca pump.The physician's assistant notified the nurse that the pca pump tubing was leaking onto the floor.The nurse assessed the tubing line and found that there was a small leak in the tubing.The tubing was removed.It was further confirmed during follow up, that there was no delay in treatment nor any patient harm or impact as a result of this event.
Additional Manufacturer Narrative
B3 - correction to date of event.
Event or Problem Description
It was reported that a patient was on a pca pump.The physician's assistant notified the nurse that the pca pump tubing was leaking onto the floor.The nurse assessed the tubing line and found that there was a small leak in the tubing.The tubing was removed.It was further confirmed during follow up, that there was no delay in treatment nor any patient harm or impact as a result of this event.

• Brand Name: ALARIS PCA MICROBORE SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9371757
• Report Number: 9616066-2019-03459
• Device Sequence Number: 14130406
• Product Code: FPA
• UDI-Device Identifier: 10885403273995
• UDI-Public: 10885403273995
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• 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,Followup
• Report Date (Section B): 11/08/2019

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: 30853
• Device Catalogue Number: 30853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 02/20/2020; 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1