MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HMOD70000-USA

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 06/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted if additional information becomes available.

Event Description

According to the customer: the customer shared that children's hospital of new orleans had used a adult quadrox id on a neonate with an adverse outcome.He reported complications with and he raised concerns about using the adult qid's with neonate.He expressed concerns regarding priming volumes and minimum flow rates.This report is in reference to baby number three.This is the third report to add to (b)(4).

Manufacturer Narrative

The clinician used the adult oxygenator for the purposes of extracorporeal oxygenation of and carbon dioxide removal from human blood for the pediatric patient due to the fact that the clinic did not have a neonate or pediatric device available.Quadrox-i adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.The device oxygenates the blood, eliminates carbon dioxide from the blood and regulates blood temperature.The quadrox-i adult (hmo 71000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 um.The device¿s utilization period is limited to six hours.Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.Several attempts were performed to obtain more information from the customer about which performance parameters he was concernd of as well about the lot # and the udi of the oxygenator in order to perform a dhr review.No information was provided up to date.The cause of this failure was determined to not be attributed to a device related malfunction.Based on these results and the information available at this time, the oxygenator in question operated within maquet cardiopulmonary specifications.

Event Description

(b)(4).

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 5805479
• MDR Text Key: 49897915
• Report Number: 8010762-2016-00470
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BEQ-HMOD70000-USA
• Device Catalogue Number: 701053824
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/21/2016
• Event Location: Hospital
• Date Report to Manufacturer: 06/21/2016
• Date Manufacturer Received: 07/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other