MAUDE Adverse Event Report: FRESENIUS HEMOCARE GMBH CATSMART

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/18/2019

Event Type  Death  

Event Description

Death of a patient.

Event Description

Death of a patient.Per call with (b)(6) (chief perfusionist) on (b)(6) 2019: patient was 91 years old with fragile tissue that kept tearing and was difficult to repair.The patient was supposed to have an abdominal surgery to repair an abdominal aortic aneurysm using endoscopy; however, it ended up being changed to an open surgery instead.They did use donor blood during the surgery.The data and logfile investigation revealed the interruption was most likely caused by a manipulation of the tube in the sensor, which rendered the sensor not detecting blood anymore.The investigation revealed that the manipulation of the tube was most likely favored by a setup of the device, the disposable and all attached accessories against manufacturer advice.Result of risk assessment: the blood processing interruption due to a not correctly working tube sensor is classified with a severity of 1-negligible.The potential harm is identified as "insufficient patient care (no or impaired transfusion product)" the overall risk is rated as "acceptable".

• Brand Name: CATSMART
• Type of Device: CATSMART
• Manufacturer (Section D): FRESENIUS HEMOCARE GMBH; gruener weg 10; friedberg hessen, D-611 69; GM D-61169
• MDR Report Key: 9474869
• MDR Text Key: 170927050
• Report Number: 3004634229-2019-00004
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• PMA/PMN Number: K160735
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 9005901
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2019
• Date Manufacturer Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death