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

Model Number VKMO 70000

Device Problem Decrease in Pressure (1490)

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

Event Date 05/05/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the hospital:"after almost 15 minutes of use (from the connection of the patient), the oxygenator module showed a high resistance to the blood flow, with the consequence of higher pressure drop.Since it was impossible to continue the procedure in this way, the oxygenator module has been replaced." (b)(4).

Manufacturer Narrative

(b)(4).The product was investigated in the laboratory of the manufacturer.The oxygenator was cleaned and sawed off.The mats were inspected according to lv 7544.Between the mats small clots were detected.No other abnormalities were detected.Dhr review: affected product: basic lot 70109322 and packaging lot 70111067 (serial number (b)(4)).The avz 7568 from (b)(4) was reviewed on 2017-09-26.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 (dms# (b)(4)),the performance tests passed the acceptance criteria.The cause of the reported failure was determined to not be attributed to a device related malfunction.The detected clots between the mats were leading to the conclusion the clotting / micro clotting was causing the observed resistance to the blood flow.Thus a product malfunction could not be confirmed.

Event Description

Ref.: # (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: 6604087
• MDR Text Key: 76601864
• Report Number: 8010762-2017-00179
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K082117
• 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: 06/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2018
• Device Model Number: VKMO 70000
• Device Catalogue Number: 701067942
• Device Lot Number: 92215006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2017
• Date Device Manufactured: 12/01/2016
• 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