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

Model Number HMOD 70000-USA

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been requested but not yet received.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

It was reported there was an incident of a ¿leaking¿ oxygenator yesterday.Oxygenator was changed out on a patient and immediately started leaking blood-tinged fluid from the outlet at the bottom of the oxygenator.Oxygenator changed out without incident." (b)(4).

Manufacturer Narrative

The product was investigated in the laboratory of the manufacturer.By tightness test a leakage from the gas outlet was confirmed.The gas side was sawed off, hereby a leakage on side 2 / row 4 and on side 4 / row 6 was detected.The leakages were caused by fiber leakages.Thus the reported failure could be confirmed.A dhr review was performed; there were no references found, which are indicating a nonconformance of the product in question.Since the reported failure did not contribute to a death or serious injury and no systemic issue could be determined no corrective action is needed at this time.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: 6099632
• MDR Text Key: 60424375
• Report Number: 8010762-2016-00672
• 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: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2016
• Device Model Number: HMOD 70000-USA
• Device Catalogue Number: 701053815
• Device Lot Number: 70111588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1