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

Model Number	ME2064
Medical Device Problem Codes	Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	05/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical product: broviac cvl; non-bd used microclave, used bd 5ml syringe.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.Additional patient information: infant; race: w.
Event or Problem Description
It was reported that the unspecified medication infusion was infusing intermittently via the infant patient's right femoral central venous line.
Additional Manufacturer Narrative
(b)(4).The customer¿s report that the tubing was infusing intermittently was confirmed; due to a leak in the filter weld line.Functional priming found a leak from the filter weld line.Closer inspection of the filter under a lab microscope observed no tool marks or scratches.No further testing could be performed due to the leak.The set was visually inspected for kinks, holes/tears in the tubing or damages to the components.No anomalies were observed anywhere on the set during initial visual inspection.Closer visual inspection under a lab microscope observed no cracks, tool marks or stress marks on the filter component.The root cause due to a supplier manufacturing error.
Event or Problem Description
It was reported that an unspecified medication infusion was infusing intermittently via the infant patient's right femoral central venous line.The customer stated during follow-up, that there was no more information available.It was further stated that there was no harm to the patient as a result of this event.

• Brand Name: ALARIS EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8786707
• Report Number: 9616066-2019-01942
• Device Sequence Number: 19417762
• Product Code: FPA
• UDI-Device Identifier: 10885403236280
• UDI-Public: 10885403236280
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

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: ME2064
• Device Catalogue Number: ME2064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 10/30/2019
• 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: 8100,8015,PRI TUBING, THERAPY DATE: (B)(6) 2019
• Patient Age: 2 MO