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

Model Number	10013072
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.Patient demographics requested however not provided.
Event or Problem Description
It was reported that during a secondary epoch infusion the user noticed that there was a leak in the silicone segment.The customer confirm that there was no patient harm when the chemo leak (50ml) occurred.
Additional Manufacturer Narrative
The customer¿s report that the tubing set was leaking was confirmed by evaluation of the customer-provided photograph.Photographic analysis confirmed that the primary set was leaking at a hole on the silicone tubing below the upper fitment.The suspect set was not returned for investigation.Although the suspect set was not returned, a new, unused associate set was returned for investigation.The returned associate set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.No tool marks or crush marks were observed on the upper fitment.No anomalies were observed with the set.Functional, pressure and infusion testing did not replicate a leak on the associate set.The source of the leak is due to a hole/damage in the silicone pump segment near the upper fitment (per photo).The root cause of the hole/damage could not be definitively determined.
Event or Problem Description
It was reported that during a secondary epoch infusion the user noticed that there was a leak in the silicone segment.The customer confirm that there was no patient harm when the chemo leak (50ml) occurred.
Additional Manufacturer Narrative
The aware date for supplemental mdr pr 322089 was inadvertently omitted from the report.The aware date was (b)(6) 2019.
Event or Problem Description
It was reported that during a secondary epoch infusion the user noticed that there was a leak in the silicone segment.The customer confirm that there was no patient harm when the chemo leak (50ml) occurred.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8709512
• Report Number: 9616066-2019-01675
• Device Sequence Number: 14049946
• Product Code: FPA
• UDI-Device Identifier: 07613203021210
• UDI-Public: 7613203021210
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• 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): 05/29/2019

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: 10013072
• Device Catalogue Number: 10013072
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 09/26/2019; 09/27/2019
• 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: MS3500-15, 8015, 8100. TD (B)(6) 2019