MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG ARDIOHELP SYSTEM; CARDIOPULMONARY SUPPORT SYSTEM

Model Number 70104.8012

Device Problem Device Stops Intermittently (1599)

Patient Problem Death (1802)

Event Date 02/07/2015

Event Type  Death  

Event Description

It was reported that the cardiohelp pump stopped flowing while the pt was being turned/moved.The blood flow could not be restored.The pt expired.It was reported that the unit went from 4 liters flow per minute to zero liters flow per minute.Add'l info: pt had an open chest.This event is related to medwatch report # 8010762-2015-00015 and 3008355164-2015-0028 (hls disposable).(b)(4).Mfr ref #: 8010762-2015-00068.

• Brand Name: ARDIOHELP SYSTEM
• Type of Device: CARDIOPULMONARY SUPPORT SYSTEM
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 4580111
• MDR Text Key: 5484356
• Report Number: 3008355164-2015-00020
• 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: 03/04/2015,02/07/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 70104.8012
• Device Catalogue Number: 70104.8012
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/07/2015
• Device Age: 15 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 68 YR