MAUDE Adverse Event Report: CAREFUSION ALARIS® PCA MODULE SET; SET, ADMINISTRATION, 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	10/01/2019
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.Additional patient information: medical hx: malignant neoplasm of left female breast-s/p lumpectomy; lumbar adjacent segment disease with spondylolisthesis-l3-4, l4-5 (b)(6) 2019; obesity; hypothyroidism; hypertension; type 2 diabetes mellitus; depression.
Event or Problem Description
It was reported that the tubing set had a hole that leaked during a dilaudid infusion which caused the patient not to receive the entire dilaudid medication dose.It is unknown how much was received by the patient.The customer later stated that there were no adverse effects caused to the patient from the event.
Additional Manufacturer Narrative
The customer¿s report that the tubing set had a hole that leaked was confirmed.The set was visually inspected as received for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.No anomalies were observed during initial visual inspection.Functional priming testing found the set leaked from the tubing approximately (10) ten, inches below the female luer.Closer inspection of the leak under a lab microscope observed a small cut damage in the tubing.The source of the leak is due to a cut in the tubing.The root cause of the cut damage could not be determined.
Event or Problem Description
It was reported that the tubing set had a hole that leaked during a dilaudid infusion which caused the patient not to receive the entire dilaudid medication dose.It is unknown how much was received by the patient.The customer later stated that there were no adverse effects caused to the patient from the event.

• Brand Name: ALARIS® PCA MODULE SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9247180
• Report Number: 9616066-2019-03044
• Device Sequence Number: 19470377
• 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): 10/03/2019

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: 10/23/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 12/30/2019
• 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: 8120, 8015, PCA SYRINGE, TD (B)(6) 2019
• Patient Age: 56 YR
• Patient Weight: 113