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

Model Number	ME2064
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/06/2020
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 an unspecified tubing issue that is possibly related to the previous events of leaks, cracks or crumbling of the fixed collar on the distal end of extension set me2017.The tubing was received with a label "amio" written on it.Although requested, additional information was not provided.
Event or Problem Description
It was reported an unspecified tubing issue that is possibly related to the previous events of leaks, cracks or crumbling of the fixed collar on the distal end of extension set me2017.The tubing was received with a label "amio" written on it.Although requested, additional information was not provided.
Additional Manufacturer Narrative
The customer reported an unspecified tubing issue.Visual inspection observed no issue with set me2017; however with set me2064, its filter had dried fluid residue within and its membrane wetted/compromised.Functional testing also observed no issue with set me2017; however with set me2064, there was a leak (termed ¿weeping out¿) from its 0.2 micron adult filter vent.The root cause of the leak was unable to be identified.Both sets were inspected for kinks, holes/tears in the tubing, or damages to the components.Functional testing of pushing fluid through set me2064 observed a leak from the filter vent.No other leak was observed.The device history record for model me2064 could not be performed due to no lot number being provided for the reported suspect set sample.

• 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: 9932861
• Report Number: 9616066-2020-01206
• Device Sequence Number: 2405601
• Product Code: FPA
• UDI-Device Identifier: 10885403236280
• UDI-Public: 10885403236280
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2020

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: 03/12/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2020
• Supplement Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1