MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG CARDIOHELP-I; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 70104.8012

Device Problems Pumping Stopped (1503); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2015

Event Type  Injury  

Event Description

It was reported that during patient support on a cardiohelp, a venous bubble detection was triggered.Pressing the re-set button did not restore flow, nor did it reset the venous bubble sensor.Universal (global) override was engaged to restore flow.(b)(4).

Manufacturer Narrative

The above reported incident was investigated and the customer responded stating the following: "we investigated this occurrence and found that the device did exactly as it was supposed to, so i feel there is no need to investigate" based on the information received it was confirmed that there was no adverse event associated with the functionality of the device and thus this issue should not have been reported.This updated reported will serve as a final report to close this issue.

Event Description

(b)(4).Note- the initial importer medwatch for this complaint was submitted on paper.The mfr did not report this event.

• Brand Name: CARDIOHELP-I
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 4744926
• MDR Text Key: 5709354
• Report Number: 3008355164-2015-00091
• Device Sequence Number: 1
• Product Code: DTZ
• 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,unknown
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2015,04/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2015
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/01/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/01/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention