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

Model Number VKMO 11000

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

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

Event Date 10/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product was requested for investigation, but not yet received.The incident investigation of the manufacturer is still pending.A supplemental medwatch will be submitted when further information becomes available.

Event Description

According to the customer: 'there was block inside the oxygenator, the blood could not go through the oxygenator.Primed with heparin and act was ok.' (b)(4).

Manufacturer Narrative

The sample was not available for return as it had been discarded and therefore a full investigation could not be completed.Based on available information the failure could not be confirmed and a root cause could not be determined.A dhr review was performed and the investigation found no abnormalities and all the controls were completed in accordance with the process control form.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.Please note this is the final report.

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: 6085813
• MDR Text Key: 59846037
• Report Number: 8010762-2016-00665
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K102464
• 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: 06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2017
• Device Model Number: VKMO 11000
• Device Catalogue Number: 701049279
• Device Lot Number: 92171754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2017
• Date Device Manufactured: 04/01/2015
• 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