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

Model Number	10933805
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/25/2019
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.Although requested, patient demographics not provided.
Event or Problem Description
Unspecified tubing event.Customer advocacy received a copy of the customer's medwatch report from the fda which states, "primary tubing leaking and cracked in multiple places.Tubing was primed with dopamine.Registered nurse noticed that air was pulling into line multiple times and needed to be re-primed line required to be changed.".
Additional Manufacturer Narrative
The customer complaint of the tube leaking and cracking was confirmed; however the received set leaked from only one place, not multiple places as reported by the customer.Functional testing was performed by filling a lab iv bag with bleach water and attaching the sets allowing fluid to flow through the whole set by gravity.The set leaked from a small hole at the top of the silicone segment (b)(4).No other leaks were observed throughout the set.Closer inspection under a lab microscope observed that the leak was due to a small hole on the silicone segment.No tool marks or crush marks were observed on the upper fitment near the small hole.The root cause could not be determined.
Event or Problem Description
Unspecified tubing event.Customer advocacy received a copy of the customer's medwatch report from the fda which states, "primary tubing leaking and cracked in multiple places.Tubing was primed with dopamine.Registered nurse noticed that air was pulling into line multiple times and needed to be re-primed line required to be changed.".

• 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: 8557403
• Report Number: 9616066-2019-01155
• Device Sequence Number: 2103548
• Product Code: FPA
• UDI-Device Identifier: 07613203019088
• UDI-Public: 7613203019088
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2019

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 Expiration Date: 11/20/2021
• Device Model Number: 10933805
• Device Catalogue Number: 10933805
• Device Lot Number: 18116294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1