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

Model Number	10800173
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
No product returned.Because no product was returned or expected to be returned, no failure investigation could be performed.The root cause of the customer's experience was not identified.
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
Correction of date of event-additional information added to: b3.
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 MODULE EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9371666
• Report Number: 9616066-2019-03457
• Device Sequence Number: 14130407
• Product Code: FPA
• UDI-Device Identifier: 10885403234385
• UDI-Public: 10885403234385
• 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
• 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: 10800173
• Device Catalogue Number: 10800173
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1