MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. PEDIATRIC KIT W/30ML FLUSH DEVICE FOR UNIV OF COLORADO; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	460990410
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product samples were returned for investigation.Additionally, no pictures or videos were provided by the customer documenting the reported issue.Therefore, a comprehensive investigation cannot be conducted and a root cause can not be evaluated.The manufacturing and design records were reviewed and no non-conformances or anomalies were found that would have contributed to the reported issue.Due to a system limitation, the date is inadvertently marked as 04/26/2019.The correct date is 5/14/2019.
Event or Problem Description
The event involved a pediatric kit with 30ml flush device that was originally reported through a voluntary medsun medwatch report #mw5085775.It was reported that air was noted in the arterial line set up.The line was prepped appropriately with the ordered fluids, but once connected to the baby a significant amount of air bubbles were noted throughout the tubing.The line was flushed, but it continued to have a ton of air bubbles throughout.A new tubing set was primed and applied.There was no report of an adverse event or delay in critical therapy.

• Brand Name: PEDIATRIC KIT W/30ML FLUSH DEVICE FOR UNIV OF COLORADO
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 8688609
• Report Number: 9617594-2019-00167
• Device Sequence Number: 14008314
• Product Code: DRS
• UDI-Device Identifier: 00887709049703
• UDI-Public: (01)00887709049703(17)210801(10)3769522
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K052828
• 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
• Report Date (Section B): 04/26/2019

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 Expiration Date: 08/01/2021
• Device Catalogue Number: 460990410
• Device Lot Number: 3769522
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1