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

Model Number	ME2064
Medical Device Problem Codes	Inaccurate Flow Rate (1249); Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: broviac central line;non-bd used microclave.The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.Additional patient information: race: w.
Event or Problem Description
It was reported that the hydrocortisone infusion was infusing intermittently via the infant patient's broviac central line located in the patients left femoral artery.
Additional Manufacturer Narrative
The customer's report of intermittent flow issues was not confirmed.The concomitant primary set that was in use at the time of the customer event was not received visual inspection of the set was done for obvious issues/damage such as kinked tubing, pin holes, tears, disengagements, cracks, fractures, contaminants, incorrect orientation, and component misassembly.No obvious issues were observed with the as-received samples.Functional testing was performed and no issues were observed.The root cause of the customer's report was not identified.
Event or Problem Description
It was reported that the hydrocortisone infusion was infusing intermittently via the infant patient's broviac central line located in the patients left femoral artery.There is no additional information available per the customer.

• Brand Name: EXTENSION SET
• Common Device Name: SET,ADMINISTRAITON,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8786708
• Report Number: 9616066-2019-01910
• Device Sequence Number: 19254819
• 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: 11/03/2019
• 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: 8015,PRI TUBING,8100, TD (B)(6) 2019
• Patient Age: 10 MO