MAUDE Adverse Event Report: CAREFUSION ALARIS PCA 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	05/15/2019
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 the pca tubing leaked while in use on a patient located on the medical/surgical unit.The customer stated that there were no adverse effects caused to the patient from the event.
Event or Problem Description
It was reported that the pca tubing leaked while in use on a patient located on the medical surgical unit.The customer stated that there were no adverse effects caused to the patient from the event.
Additional Manufacturer Narrative
All patient demographics were requested however not provided.The customer¿s report that the pca tubing leaked was confirmed.Inspection noted multiple slices along the microbore tubing located between the antisiphon valve and y-site components.The damage was noted to be located approximately 35 1/2 inches of the tubing starting from approximately 20 inches below the antisyphon valve component.Fluid was pushed through and leaks were observed from the noted damage.The sets were also pressure tested while submerged underwater.Leaking was identified in the same location.The cause of the leak was due to the tubing damage.The root cause of the tubing damage was not identified.

• Brand Name: ALARIS PCA EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8686795
• Report Number: 9616066-2019-01596
• Device Sequence Number: 2358923
• 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: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 09/10/2019
• 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,NON BD EXTENSION SET,8120, TD (B)(6) 2019; 8015,NON BD EXTENSION SET,8120, TD (B)(6) 2019
• Patient Age: 71 YR