MAUDE Adverse Event Report: 70104.8012# CARDIOHELP-I

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Type  Death  

Event Description

(b)(4).

Manufacturer Narrative

The manufacturer performed a review of the device history records (dhr), which were created during the manufacturing process of coating the product.No deviations were found.A clinical evaluation of available information, including the log-files of the cardiohelp device was performed.Laboratory values show a very critically ill patient with anemia.It was identified that the performance of the priming procedure according to the ifu (instructions for use) was not supported by the log files.No sensor intervention was enabled.In addition, the anticoagulation protocol could not be obtained.Therefore, it cannot be confirmed that anticoagulation control was performed according to the ifu.The log files also show that perfusion was initiated even though the "global override" mode had been activated against the directions provided in the ifu.In addition, air entered the perfusion system.Therefore the first bubble detection was not signaled acoustically but visually with prompt reaction of the user by resetting the bubble sensor.When air entered the perfusion system for the second time it was signaled acoustically and visually due to the deactivated "global override" mode.The pressure drop of the integrated pressure measurement values and the action of increasing the pressure warning and pressure alarm limits during the incident is documented in the log files but are not reasonably comprehensible from a clinical perspective.The root cause of the incident is clinically unknown due to insufficient information.The service order is still pending.A supplemental medwatch will be submitted if additional information becomes available.Reference exemption # (b)(4).

• Brand Name: 70104.8012# CARDIOHELP-I
• Type of Device: CARDIOHELP-I
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 9737097753
• MDR Report Key: 4635863
• MDR Text Key: 5612243
• Report Number: 8010762-2015-00290
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 02/24/2015
• Initial Date FDA Received: 03/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1