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

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2019

Event Type  malfunction  

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 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
• Type of Device: 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
• Manufacturer Contact: emily arnould, bsn, rn ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 8688609
• MDR Text Key: 198329614
• Report Number: 9617594-2019-00167
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00887709049703
• UDI-Public: (01)00887709049703(17)210801(10)3769522
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2021
• Device Catalogue Number: 460990410
• Device Lot Number: 3769522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1