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

Model Number BE-HMOD 30000

Device Problems Occlusion Within Device (1423); No Flow (2991)

Patient Problem No Information (3190)

Event Date 09/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product was requested for the manufacturers laboratory investigation.The investigation is still pending.A supplemental medwatch will be submitted when additional information becomes available.

Event Description

According to the surgeon, who was responsible for the surgery, a circulatory support system (ecmo) was initiated for a child, immediate postoperative for aortic arch hypoplasia correction of transposition of the great arteries.On the first day of ecmo, the machine couldn't give flow.Suspected presence of thrombus in the oxygenator membrane.The product was exchanged.(b)(4).

Manufacturer Narrative

(b)(4).The sample was returned on (b)(6) 2017 and it was investigated in the complaints laboratory at the site in hechingen.During the rinsing of the quadrox-i pediatric, no clots were flushed out.The dhr review showed no deviations.The sample was investigated and the failure could not be confirmed.There was no evidence of a production issue, and the conclusion of the investigation is that the issue is not related to a product-related failure, and the most likely root cause would be related to a clinical or application-related issue.No systemic issue was identified from the complaint database review but the data, however, will continue to be monitored and if a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further investigation or action is warranted at this time and the complaint will be closed.

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: 6052096
• MDR Text Key: 58604581
• Report Number: 8010762-2016-00642
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K100278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2016
• Device Model Number: BE-HMOD 30000
• Device Catalogue Number: 701047041
• Device Lot Number: 70102771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2016
• Date Device Manufactured: 11/01/2014
• 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