MAUDE Adverse Event Report: HUMMINGBIRD MED DEVICES INC HUMMI TRANSFER DEVICE; SYSTEM, BLOOD COLLECTION

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 10/20/2019

Event Type  malfunction  

Event Description

Per report from the nicu rn, during an arterial blood gas being drawn with the hummi transfer device, during the waste portion, the blood leaked "everywhere." the tubing up by the hub was severed.The rn was able to clamp off the tubing.There was no harm to the infant.

• Brand Name: HUMMI TRANSFER DEVICE
• Type of Device: SYSTEM, BLOOD COLLECTION
• Manufacturer (Section D): HUMMINGBIRD MED DEVICES INC; 1283 elger bay road ste d; 1283 elger bay road ste d WA 98282
• MDR Report Key: 9488616
• MDR Text Key: 171826844
• Report Number: 9488616
• Device Sequence Number: 1
• Product Code: KST
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2019
• Date Report to Manufacturer: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1