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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Inflammation (1932)

Event Date 01/31/2016

Event Type  malfunction  

Manufacturer Narrative

Update 03/18/2016 02:05 pm (b)(4): maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4). The product was scrapped by the hospital; therefore manufacturer laboratory investigation was not possible. The complaint was determined to be potentially related to the medical device recall notice for hls set advanced dated february 23, 2016 in the us. This data will be handled trough a designated maquet trending process. If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.

Event Description

Update 03/18/2016 02:10 pm ((b)(4)): it was reported a patient on ecls support was exhibiting what was believed were signs of an inflammatory response. They referenced the recent endotoxin letter and conveyed that the serial number on the quadrox-id oxygenator in use was noted in the letter. They expressed concern that the observations of this patient and the issue described in the letter may be related. Their primary concern was that the patient would be going to surgery on (b)(6) 2016 and they desired to have an oxygenator which was not included in the endotoxin letter. The exact product identity and lot# was not forwarded to the manufacturer yet. (b)(4).

Manufacturer Narrative

The quadrox-id oxygenator was returned to the factory and investigated. Due to the product being contaminated, only a visual inspection could be carried out. No blood clots were visible on either the blood inlet or outlet side of the oxygenator. The serial number / udi and the lot number of the oxygenator were photographically documented. Due to the high risk of infection posed by the disposable, it was disposed off appropriately after the visual inspection. The conclusion was that no clotting or any other anomalies could be established. A clinical assessment of this issue was carried out by the director for clinical risk management & documentation. Taking all the available information into account, he concluded that there is no indication that endotoxins from a maquet oxygenator is related to the state of the patient due to the following facts: 1)the patient had developed endocarditis prior to admission of the hospital. 2)elevated levels of d-dimers and fibrinogen is a typical finding in patients suffering from severe infections. 3), after the heart valve (source of infection) was resected and a new valve was placed, the patient recovered. Note: without ecmo and heart surgery, the patient would probably not have been able to survive; this was a successful treatment of an extremely sick patient. A correlation between elevated acute phase proteins and the maquet oxygenator cannot be confirmed.

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: 5513317
• MDR Text Key: 41372698
• Report Number: 8010762-2016-00198
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K101153
• 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: 06/26/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial