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

Model Number	2452-0007
Medical Device Problem Codes	Fluid/Blood Leak (1250); Failure to Prime (1492); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
Event or Problem Description
It was reported that the iv tubing has a hole in it as it would not prime and kept getting air.The nurse finally noticed fluid dripping out of the tubing's fitment.The event occurred during priming of normal saline.There was no patient involvement.
Additional Manufacturer Narrative
The customers report that the iv tubing has a hole and is leaking was confirmed.The set was inspected for kinks, holes/tears in the tubing or damages to the components, and no obvious damages or issues were observed.During further visual inspection a pinhole was observed on the silicone segment at the engagement area to the upper fitment.Testing confirmed a leak from the pinhole as well as air bubbles within the silicone segment during repriming of the set.Functional testing confirmed a leak from the pinhole as well as air bubbles within the silicone segment during repriming of the set.The root cause of the damage was not identified.
Event or Problem Description
It was reported that the iv tubing has a hole in it, as it would not prime and kept getting air.The rn finally noticed fluid dripping out of the tubing's fitment.The event occurred during priming of normal saline.It was confirmed that there was no patient involvement.

• 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: 9221944
• Report Number: 9616066-2019-02918
• Device Sequence Number: 13989652
• Product Code: FPA
• UDI-Device Identifier: 10885403219870
• UDI-Public: 10885403219870
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2019

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: 07/21/2022
• Device Model Number: 2452-0007
• Device Catalogue Number: 2452-0007
• Device Lot Number: 19076207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1