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 07/19/2019

Event Type  Death  

Event Description

Death.

Event Description

Death of a patient.Customer reported the patient died following an on (b)(6) 2017 surgery at (b)(6) hospital.Apparently, the patient developed disseminated intravascular coagulation (dic) the patient's blood became contaminated (with what is currently unknown) and, upon the reinfusion of cell saver material, the patient expired.The reported issue will be noted but could not be reproduced.Fresenius kabi tried to obtain information form the customer on multiple occasions.Very little information was received.The involved device could not be identified, therefore no data about device service history or service activities after the incident were available.The autopsy report was analysed with a consultant clinical expert.According to the consultant clinical expert, the autopsy report does not contain sufficient information to make a precise statement regarding a potential device related problem.No root cause could be identified with the received information.

• 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: 8895376
• MDR Text Key: 154360206
• Report Number: 3004634229-2019-00002
• 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: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• 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: 9005081
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/19/2019
• Date Manufacturer Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death