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

Model Number	30893-07
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Type of Reportable Event	Malfunction
Additional 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.Although requested, information was not provided.
Event or Problem Description
It was reported that female patients during labor was not receiving adequate dosing of fentanyl/bupivacaine medications due to epidural iv tubing set leaking at the engagement of the male luer, resulting in patients not receiving adequate dosing of epidural medication.Rn had to replace iv tubing sets and get patients' pain under control.
Event or Problem Description
It was reported that the epidural iv tubing set leaking at the engagement of the male luer, resulting in the patients not receiving adequate dosage of fentanyl /bupivacaine during labor.The nurse replaced the iv tubing sets and got the patients' pain under control.
Additional Manufacturer Narrative
The customer¿s report of epidural iv tubing set leaking at the engagement of the male luer was confirmed.The set samples were visually inspected for kinks, holes/tears in the tubing or damages to the components.No issues were observed.Functional testing was performed.The leaks occurred at the engagement between the microbore pvc yellow stripe tubing and male luer components.Further observation under magnification revealed some solvent anomalies that seemed more evident along the area of the yellow stripes of the microbore tubings.The root cause of epidural iv tubing set leaking at the engagement of the male luer was a manufacturing issue.
Event or Problem Description
It was reported that female patients during labor were not receiving adequate dosing of fentanyl /bupivacaine medications due to epidural iv tubing set leaking at the engagement of the male luer, resulting in the patient's not receiving adequate dosing of epidural medication.The nurse had to replace the iv tubing sets and get the patients' pain under control.
Additional Manufacturer Narrative
Additional information/updated: section b.5.
Event or Problem Description
It was reported that the epidural iv tubing set leaking at the engagement of the male luer, resulting in the patients not receiving adequate dosage of fentanyl /bupivacaine during labor.The nurse replaced the iv tubing sets and got the patients' pain under control.

• Brand Name: ALARIS PCEA ADMINISTRATION SET MICROBORE TUBING
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9490320
• Report Number: 9616066-2019-03623
• Device Sequence Number: 1384987
• Product Code: FPA
• UDI-Device Identifier: 10885403460234
• UDI-Public: 10885403460234
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/26/2019

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
• Operator of Device: Health Professional
• Device Model Number: 30893-07
• Device Catalogue Number: 30893-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 03/13/2020; 03/20/2020; 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0386-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8015, 8120; THERAPY DATE: UNKNOWN