MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HCU 30; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Death (1802)

Event Date 03/15/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).The device can not be investigated or tested to contamination.Also the hospital did not know which device was used during the cardiac bypass surgery.Therefore no investigation results are available and the article no.And also the serial no.Of the unit are missing.A supplemental medwatch will be submitted if new information has been received.

Event Description

It was reported that a patient died on (b)(6) 2016, after a cardiac bypass surgery, which was performed on (b)(6) 2016.The patient died due to mycobacterium avium (according to the tb culture report).The suspicion from the patient's family is, that the used hcu30 was contaminated with mycobacterium chimaera and contributed to the infection from the patient.(b)(4).

Manufacturer Narrative

Bypass cardiac surgery was performed on a patient on (b)(6) 2016.Nine months later ((b)(6) 2016) the patient died due lung infection caused by mycobacterium avium (according to the tb culture report).The patient's family inquired if the hcu30 could have contributed to the infection that may have resulted in the death of the patient.A formal response was provided by dr.(b)(6) (maquet clinical director) as follows: the hospital could not trace the device that was used during the operation.As background information, he provided information regarding a study that was performed in relation to an hcu device to determine if any bacterial contamination could be transferred from the device to a patient during surgery.For that particular study of over 100 case since 2013, it was confirmed that at the site of manufacture of the particular heater cooler device, bacterial contamination strain of mycobacterium chimaera was found and this was comparative to those found in these surgeries performed with respect to open heart surgeries.The complaint assessment however determined that no mycobacterium chimaera contamination was ever found in the lungs of any patients.Mycobacterium avium was the isolate found in the patient.It was also stated that mycobacterium avium has never been isolated from any heater cooling device.Thus, taking into consideration the above, there is no definite link of the hcu 30 being implicated in any bacterial contamination infection of the patient.

Event Description

(b)(4).

• Brand Name: MAQUET HCU 30
• Type of Device: CONTROLLER, TEMPERATURE, 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: 6566855
• MDR Text Key: 75146079
• Report Number: 8010762-2017-00151
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K031544
• 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: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death