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

Model Number	2232-0007
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	12/14/2019
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 tubing set was found to have a hole in it during priming.There was no patient involvement.
Additional Manufacturer Narrative
Additional information added; section; b.5.(patient/event information clarified/detailed), and h.6.(patient code).The customer¿s report that the tubing set was found to have a hole in it was confirmed.The set was visually inspected as received for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection of the set noted a small cut below the drip chamber.No other anomalies were observed.Functional testing confirmed leaking from the cut in the tubing.No other leaks were observed throughout the set.The source of the leak is due to a cut in the tubing.The root cause of the cut damage was not determined.
Event or Problem Description
It was reported that the tubing set was found to have a hole in it during priming.It was further confirmed during follow up, that the "product never reached the patient", and therefore; there was no patient involvement.Subsequently, there was no patient harm or impact as a result of this event.

• 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: 9678609
• Report Number: 9616066-2020-00363
• Device Sequence Number: 379311
• Product Code: FPA
• UDI-Device Identifier: 10885403463969
• UDI-Public: 10885403463969
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• 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): 01/20/2020

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 Expiration Date: 11/26/2021
• Device Model Number: 2232-0007
• Device Catalogue Number: 2232-0007
• Device Lot Number: 18116045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1