MAUDE Adverse Event Report: FRESENIUS KABI USA, LLC FRESENIUS KADI CATSMART AUTOTRANSFUSION SYSTEM; APPARATUS AUTOTRANSFUSION

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 10/30/2018

Event Type  malfunction  

Event Description

Saline pump failure.Wash blood flow failure.Broken connection pin.Broken connection pin on air detector.Fixed on site by mfr.

• Brand Name: FRESENIUS KADI CATSMART AUTOTRANSFUSION SYSTEM
• Type of Device: APPARATUS AUTOTRANSFUSION
• Manufacturer (Section D): FRESENIUS KABI USA, LLC; 3 corporate dr.; lake zurich IL 60047
• MDR Report Key: 8160377
• MDR Text Key: 130467556
• Report Number: MW5082078
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/03/2018
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 87