MAUDE Adverse Event Report: CAREFUSION ALARIS PCEA ADMINISTRATION SET MICROBORE TUBING; SET, EXTENSION, INTRAVASCULAR

Model Number 30893-07

Device Problem Fluid/Blood Leak (1250)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/03/2019

Event Type  malfunction  

Manufacturer Narrative

The customer¿s report that the tubing set leaked was confirmed.The leaks occurred at the engagements between the microbore tubing and the male luer adapter.Further observation under microscope revealed some solvent anomalies that seemed more evident along the area of the yellow stripe of the microbore tubing.The sets were visually inspected for obvious damage such as incomplete bonding engagements, cracks, fractures, kinks, holes, and tears in the tubing and its components.A residual clear, colorless liquid was present within the sets.No anomalies or evidence of damage on the sets or components were observed upon initial visual inspection.Functional testing was performed and small droplets were observed at the engagement between the tubing and the inlet port of the male luer.The root cause is improper solvent application due to inadequate maintenance of the solvent dispenser and an improper holding time.This creates an inadequate interaction at the affected engagement that can lead to leaks after sterilization.

Event Description

It was reported that the tubing leaked.The female patient in labor had epidural placed and bolus given by anesthesia.The patient was comfortable.About (2) hours later, the patient was in a lot of pain.The rn checked the epidural catheter, it remained in place.The rn called anesthesia to the room to check the tubing.They found the bed and pillow were very wet.Anesthesia felt that the filter may have been leaking.The patient was bolused and new tubing primed and filter was removed by anesthesia.After a couple of minutes, the new tubing was leaking in the same area as previous tubing.Anesthesia suggested it may be a bad lot.The lot number was checked and (3) more tubings with that lot were found and removed.A different lot number was obtained, primed and attached to the patient.There was no leaking observed and there were no further issues.

• Brand Name: ALARIS PCEA ADMINISTRATION SET MICROBORE TUBING
• Type of Device: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: sylvia ventura ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9272711
• MDR Text Key: 178423510
• Report Number: 9616066-2019-03072
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403460234
• UDI-Public: 10885403460234
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/07/2019

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: 02/06/2022
• Device Model Number: 30893-07
• Device Catalogue Number: 30893-07
• Device Lot Number: 19025228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Weight: 88