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 Type  Injury  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet (b)(4).As per the clinical assessment and according to the ifu quadrox-id adult the device is oxygenating blood, removes carbon dioxid from the blood and regulates the blood temperature within the specified flow rate range.The products minimun blood flow starts at 0.5 l/min.A baby / neonate usually requires an blood flow of 80 to 120 ml/min.For this application the quadrox-id pediatric with a blood flow rate of 0.2 - 2.8 l/min or the quadrox-i neonatal with a blood flow rate of 0.2 to 1.5 l/min seems to be more adequate.To use an product for neonates which is designed for adults is inadequate and it should be clear that the specifications of the quadrox id adult are inappropriate for neonates.Several attempts were peformed to obtain more information from the customer about which performance parameters he was concernced 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.Based on this the most probable cause of the reported incident is an user error.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.A supplemental medwatch will be submitted when further information becomes available.(b)(4).

Event Description

The customer shared that (b)(6) hospital of (b)(6) had used two adult qids on two different neonates.He reported complications with both and he raised concerns about using the adult qid's with neonates.He expressed concerns regarding priming volumes and minimum flow rates.This report is in reference to baby number two.No specific information was shared regarding the baby.

Manufacturer Narrative

In the previous mdr our initial review of the information led it to an incorrect assessment that the issue identified was due to user error.After further review of the information provided, this was not the case.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.

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: 5702217
• MDR Text Key: 46660677
• Report Number: 8010762-2016-00367
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HMOD70000-USA
• Device Catalogue Number: 70105.3824
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/18/2016
• Event Location: Hospital
• Date Report to Manufacturer: 05/18/2016
• 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