MAUDE Adverse Event Report: FRESENIUS KABI; SEPARATOR, AUTOMATED, BLOOD CELL

Lot Number FA18D11124

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 08/06/2019

Event Type  malfunction  

Event Description

At 10 liters processed, the disposable tubing kit on the amicus broke in the centrifuge, which caused a leak in the system.The patient lost 163 ml of whole blood.

• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL
• Manufacturer (Section D): FRESENIUS KABI; three corporate drive; lake zurich IL 60047
• MDR Report Key: 8916186
• MDR Text Key: 155167486
• Report Number: 8916186
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: FA18D11124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/07/2019
• Date Report to Manufacturer: 08/19/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26645 DA