MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG 70104.8012# CARDIOHELP-I

Model Number 70104.8012

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

Patient Problem Death (1802)

Event Date 01/02/2015

Event Type  Death  

Event Description

It was reported that the customer verbalized disappointment that maquet did not provide clinical support for safe care with this their first cardiohelp.Cardiohelp therapy was withdrawn and the patient expired.(b)(4).

• Brand Name: 70104.8012# CARDIOHELP-I
• Type of Device: CARDIOHELP-I
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 4752309
• MDR Text Key: 5772515
• Report Number: 3008355164-2015-00080
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/05/2015,04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 70104.8012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/06/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death