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

Model Number BEQ-HMOD70000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Low Oxygen Saturation (2477)

Event Date 07/29/2017

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).The device has been requested but not returned.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Oxygenator failed abruptly.Doctor reported "black blood coming in and out".The oxygenator stopped allowing gas exchange.The customer noticed this because the color of the blood coming out was the same color as going in, and there was a drop in po2.(b)(4).

Manufacturer Narrative

The product was investigated in the laboratory of the manufacturer.By visual inspection clots were detected at the blood inlet and at the blood outlet side of the product.During rinsing of the product small clots were flushed out.No further abnormalities were detected.Affected packaging lot 70115550 was reviewed on (b)(6) 2017.There were no references found, which are indicating a nonconformance of the product in question.Additionally a review of the weekly performance monitoring according to (b)(4) has been reviewed (b)(4), the performance tests passed the acceptance criteria.Based on the results obtained within the investigation at this time the cause of the reported failure was determined to not be attributed to a device related malfunction.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

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: 6810249
• MDR Text Key: 83493706
• Report Number: 8010762-2017-00271
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K082117
• 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: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2017
• Device Model Number: BEQ-HMOD70000
• Device Catalogue Number: 701053824
• Device Lot Number: 70110006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2017
• Initial Date FDA Received: 08/22/2017
• Supplement Dates Manufacturer Received: 10/20/2017
• Supplement Dates FDA Received: 10/24/2017
• Date Device Manufactured: 03/01/2016
• 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