MAUDE Adverse Event Report: CAREFUSION ALARIS PCA EXTENSION SET; SET, EXTENSION, INTRAVASCULAR

Model Number	10800173
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Pain (1994); Therapeutic Effects, Unexpected (2099); Inadequate Pain Relief (2388)
Date of Event	04/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer¿s report of cracked and leaking tubing was confirmed to be cut and leaking tubing visual inspection found multiple cuts in the tubing (p/n 605980-000).Functional testing was performed.The set leaked from the previously observed cuts in the tubing.Closer inspection under a lab microscope observed the cuts to be spread randomly throughout the tubing.The cuts were different in length and directed in different directions.The root cause of the tubing leak was due to multiple cuts in the tubing.The root cause of the cuts could not be identified.
Event or Problem Description
It was reported that pca tubing cracked and leaked dilaudid onto the floor.The set was being used on a patient that was status post wound debridement, washout, and wound vac placement.This event caused the patient severe pain, as they did not receive most of their dose.There was no other patient harm.

• Brand Name: ALARIS PCA EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8586419
• Report Number: 9616066-2019-01196
• Device Sequence Number: 2191659
• Product Code: FPA
• UDI-Device Identifier: 10885403234385
• UDI-Public: 10885403234385
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10800173
• Device Catalogue Number: 10800173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2019
• 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: 8120, 8015, THERAPY DATE (B)(6) 2019
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR