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

Model Number 70104.8012

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

Patient Problem Death (1802)

Event Date 02/23/2015

Event Type  Death  

Event Description

It was reported that the cardiohelp did not support the patient as expected.All pressures being displayed on the machine (part, pven and deltap) dropped.Rpms stayed roughly at 4000 rpms and flow dropped from 4.5l/min.To nearly 1 l/min.In addition it was reported that it was not possible to get the flow back up and there was no support of the patient.The patient expired.The patient was supported with 4.51/min.Therefore a 17fr.Arterial cannula from medtronic and a venous 24fr.Cannula from maquet was used.Anticoagulation was done with heparin before the crash.One blood gas analysis was performed during the incident and showed low ph, high lactate, high potassium and low hb.The customer reported that there were no alarms went off during this incident.(b)(4).This event is related to medwatch report # 8010762-2015-00299 and 3008355164-2015-00052 for the hls set that was used.Reference mfr # 8010762-2015-00290.

• Brand Name: 70104.8012# CARDIOHELP-I
• Type of Device: CARDIOHELLP-I
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET MEDICAL SYSTEMS USA; 45 barbour pond drive; wayne NJ 07470 000
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470-0000
• MDR Report Key: 4636083
• MDR Text Key: 19498676
• Report Number: 3008355164-2015-00046
• Device Sequence Number: 1
• Product Code: DTQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2015,02/24/2015

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/24/2015
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 60 YR
• Patient Weight: 102