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

Model Number BO-VKMO 70000

Device Problem Fluid/Blood Leak (1250)

Patient Problem Alteration In Body Temperature (2682)

Event Date 09/13/2017

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:"just after the beginning of extracorporeal circulation a blood leakage was noticed from arterial side dialysis lock and valve of the oxigenator module, at the blood outlet connector.Due to the great amount of blood leakage, oxigenator module was replaced after patient cooling procedure till 28°c and interruption of extracorporeal circulation for 2'45''.After the replacement the patient was heated again till 35°c." (b)(4).

Manufacturer Narrative

Maquet cardiopulmonary (b)(4) received the quadrox-i adult back.Leak test was performed in the laboratory of manufacturer.A leak at the luer lock of the blood inlet connector was detected.Due to the several cracks on the luer lock can not properly build up the pressure.Cracks on the ll were glued, leak test carried out again.A second leak was detected on the ll.Pur in the ll results in luer lock and as a result the cone of the screw cap can not properly seal / seal the luer.To make the drop visible, the drop was colored.Luer lock was glued.Tightness test performed again.After about 24 hours, a very slight leak on the spring on dialysis lock & valve can be seen.No further abnormalities noted.Again.After about 24 hours, a very slight leak on the spring on dialysis lock & valve can be seen.No further abnormalities noted.No leakage was found on pos#11 blood outlet 3/8 connector which is reported in the initial report.Therefore the failure 'leakage on 3/8 connector' could not confirmed.Further investigation is currently not possible for safety reasons.Corresponding measures have already been initiated.Once these measures implemented, the investigation can be resumed.Trend search was performed (material 70106.7948, failure code 0107 outlet connector) which came to following results: 0 complaints were recorded in last 12 months.Based on the sales figures of the last 12 months following occurrence rate has been calculated: 0,02%, which is below 1%.Due to this information no systemic issue could be determined.Device history record was reviewed.There were no references found, which are indicating a non conformance of the product in question.This complaint will be monitored.This complaint is now closed.

Event Description

Ref.: # (b)(4), customer 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: 6891057
• MDR Text Key: 87470611
• Report Number: 8010762-2017-00310
• 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: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2019
• Device Model Number: BO-VKMO 70000
• Device Catalogue Number: 701067948
• Device Lot Number: 92226147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2018
• Date Device Manufactured: 04/01/2017
• 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