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

Model Number 2420-0007

Device Problems Fluid/Blood Leak (1250); Misassembled (1398)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2019

Event Type  malfunction  

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.No additional patient information is available.

Event Description

Received a copy of the customer's medwatch report from the fda which states, "nurse was attempting to prime iv tubing v/hen fluid was running out the end port closest to patient has an offshoot that is not capped and is open." the event occurred in the emergency department.

Manufacturer Narrative

The customer¿s report that the set had an incorrect piece at the end was confirmed.Visual inspection of the set noted an inverted smartsite valve attached instead of the expected male luer component based on set assembly drawing.No other misassembly or issues were observed.Functional testing was deemed unnecessary due to the obvious misassembly.The root cause was due to a misassembly of the set during its manufacturing process.

Event Description

Customer advocacy received a copy of the customer's medwatch report from the fda which states, "nurse was attempting to prime iv tubing v/hen fluid was running out the end port closest to patient has an offshoot that is not capped and is open." an incomplete date of event of (b)(6) 2019 was provided.The event occurred in the emergency department.Follow up confirmed that there was no patient harm as a result of this event.Received a copy of the customer's additional information letter from fda which states, ¿nurse was attempting to prime iv tubing when fluid was running out the end.Port closest to patient has an offshoot that is not capped and is open.".

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9533589
• MDR Text Key: 179420325
• Report Number: 9616066-2019-03752
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 7613203021012
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2022
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 19105908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1