MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH OGYGENATOR WITH INTEGRATED HEAT EXCHANGER; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BE-HMOD 30000#BE-QU

Device Problem Defective Device (2588)

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

Event Date 03/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).Maquet cardiopulmonary (b)(4) requested the product for investigation but the product was not available.Therefore no laboratory investigation could be performed by the manufacturer.A review for similar complaints to be investigated already was performed and no similar complaints were found.Thus the reported failure could not be confirmed.Based on the information available at this time the cause of this failure was determined to not be attributed to a device related malfunction.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.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

They reported a faulty oxygenator.Delta p was very high, more than 100 and oxygenation started coming down.The device was replaced during treatment.No harm to the patient was reported.(b)(4).

• Brand Name: OGYGENATOR WITH INTEGRATED HEAT EXCHANGER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• 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: 8452155
• MDR Text Key: 140124257
• Report Number: 8010762-2019-00079
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K100278
• 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
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2020
• Device Model Number: BE-HMOD 30000#BE-QU
• Device Catalogue Number: 701047041
• Device Lot Number: 70123308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2019
• 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
• Patient Outcome(s): Required Intervention