MAUDE Adverse Event Report: CAREFUSION ALARIS PRESSURE SENSING MODULE SET; SET, EXTENSION, INTRAVASCULAR

Model Number 10014914

Device Problem Failure to Prime (1492)

Patient Problem No Information (3190)

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.

Event Description

It was reported that the tubing failed to prime.It was not reported that patient care was delayed and it did not contribute to, or result in serious adverse impact to patient.

Manufacturer Narrative

Correction; e.1, e.2, and g.3.The customer¿s report that the tubing failed to prime was confirmed based on functional testing.Functional testing observed that fluid was not able to flow due to excess solvent at the engagement between the tubing and male luer components.The set sample was visually inspected for kinks, holes/tears in the tubing or damages to the components.The set was attempted to be re-primed using a blue dyed fluid filled lab syringe.It was observed there was resistance and the fluid would not flow past the engagement of the micro-bore tubing and male luer components.The tubing area directly above the male luer was manually cut.The fluid was now able to exit the cut tubing end.Visual inspection under magnification through the tubing to the male luer observed an occlusion identified as excess solvent.The root cause was identified as a manufacturing issue of excess solvent at the tubing engagement.

Event Description

It was reported that the tubing failed to prime.It was not reported that patient care was delayed and it did not contribute to, or result in serious adverse impact to patient.

• Brand Name: ALARIS PRESSURE SENSING MODULE SET
• Type of Device: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9532345
• MDR Text Key: 179420379
• Report Number: 9616066-2019-03772
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403233906
• UDI-Public: 10885403233906
• Combination Product (y/n): N
• PMA/PMN Number: K811885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2022
• Device Model Number: 10014914
• Device Catalogue Number: 10014914
• Device Lot Number: 19087377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1