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

Model Number	30893-07
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that; epidural iv tubing sets were leaking at the engagement of the male luer, resulting in female labor patients not receiving adequate dosing of fentanyl/bupivacaine.The rn replaced the iv tubing sets, enabling patients to receive the correct dosage of medication and got pain under control.There was no patient impact.
Event or Problem Description
It was reported that; epidural iv tubing sets were leaking at the engagement of the male luer, resulting in female labor patients not receiving adequate dosing of fentanyl /bupivacaine.The nurse replaced the iv tubing sets, enabling the patients to receive the correct dosage of medication and got pain under control.It was further confirmed during follow up, that there was no patient harm or impact as a result of this event.
Additional Manufacturer Narrative
Correction; e.2, e.3, and g.3.The customer¿s report that the epidural iv tubing set was leaking at the engagement of the male luer was confirmed.The leak occurred at the engagement between the microbore tubing and the male luer adapter.Further observation revealed some solvent anomalies that seemed more evident along the area of the yellow stripe of the microbore tubing.The set was visually inspected for obvious damage such as incomplete bonding engagements, cracks, fractures, kinks, holes, and tears in the tubing and its components.Functional testing was performed and small droplets were observed at the engagement between the tubing and the inlet port of the male luer.The set was then pressure tested while submerged underwater.Air pressure was incrementally increased and no leaks were observed during pressure testing.Although there are multiple contributing factors, the predominant root cause is improper solvent application due to inadequate maintenance of the solvent dispenser and an improper holding time.

• Brand Name: ALARIS PCEA ADMINISTRATION SET MICROBORE TUBING
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9403548
• Report Number: 9616066-2019-03492
• Device Sequence Number: 18944558
• 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: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2019

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 Expiration Date: 04/24/2022
• Device Model Number: 30893-07
• Device Catalogue Number: 30893-07
• Device Lot Number: 19046125
• 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
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 02/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1