MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET CARDIOHELP

Model Number 70104.8012

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

Patient Problem Death (1802)

Event Date 07/31/2014

Event Type  Death  

Event Description

Originally it was reported that no error on a cardiohelp was noticed while transporting a pt.Then it was reported that while transporting a pt on a plane, there was a no flow situation regarding a sechrist air oxygen mixer (blender) being used in conjunction with a cardiohelp device.One of the two air supply pumps quit working and the blender bleed-off alarm activated.Someone then selected 100% fio2 while they shut off the blender flow meter.It was then noted that the blood got dark and the pt coded.Additional info provided on (b)(6) 2014 - during pt transport the bubble sensor clamp popped open and the rpm indicator portion of the screen blinked on and off.(b)(4).

Manufacturer Narrative

(b)(4).Maquet provides product failure investigation, analysis and resolution for the device described in this report.A maquet service technician explained via phone call with a nurse, an engineer, and the flight nurse, that if they turned off the gas flow, then the oxygenator would not receive any gas and it wouldn't matter what the fio2 setting was, there was no gas flow to allow any ventilation to the oxygenator.After this conversation they seemed to understand that the event was related to how a blender works and not the cardiohelp function.The cardiohelp device has been requested for return to perform eval.A supplemental medwatch will be submitted if additional info becomes available.(b)(4).

• Brand Name: MAQUET CARDIOHELP
• Type of Device: CARDIOHELP
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt 7643 7; GM 76437
• Manufacturer Contact: janice krebs ; 45 barbour pond dr.; wayne, NJ 07470 ; 9737097359
• MDR Report Key: 4113768
• MDR Text Key: 18031456
• Report Number: 8010762-2014-00324
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/03/2014,08/05/2014

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/05/2014
• Event Location: Other
• Date Report to Manufacturer: 08/07/2014
• Initial Date Manufacturer Received: 08/05/2014
• Initial Date FDA Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death