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

Model Number 30893-07

Device Problem Fluid/Blood Leak (1250)

Patient Problems Inadequate Pain Relief (2388); Underdose (2542)

Event Date 07/03/2018

Event Type  Injury  

Manufacturer Narrative

The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.

Event Description

The customer reported the patient continued to have pain despite having a continuous epidural infusion of ropivacaine.The epidural tubing was assessed and leakage was found at the tubing-to-male luer engagement of the epidural set.While priming the replacement set, fluid leaked from the same engagement on the new set.The third set was primed without leakage.There was no report of patient harm.

Manufacturer Narrative

The customer¿s report of a tubing leak was confirmed.No anomalies or evidence of damage on the set or components were observed upon initial visual inspection.Functional testing was performed and a leak occurred at the engagement between the microbore tubing and the male luer adapter.Further observation under magnification revealed some solvent anomalies that seemed more evident along the area of the yellow stripe of the microbore tubing.The root cause of the tubing leak is unknown.

Event Description

The customer reported the patient continued to have pain despite having a continuous epidural infusion of ropivacaine.The epidural tubing was assessed and leakage was found at the tubing-to-male luer engagement of the epidural set.While priming the replacement set, fluid leaked from the same engagement on the new set.The third set was primed without leakage.There was no report of patient harm.

• Brand Name: ALARIS PCA MODULE SET
• Type of Device: SET, ADMINISTRATION, 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: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 7774130
• MDR Text Key: 116804808
• Report Number: 9616066-2018-01274
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2020
• Device Model Number: 30893-07
• Device Catalogue Number: 30893-07
• Device Lot Number: 17096980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2017
• 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
• Treatment: 8120,8015,SYRINGE, TD: (B)(6) 2018
• Patient Outcome(s): Other