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

Model Number BE-HMOD 30000

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 07/18/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the customer: pediatric patient with diagnosis of respiratory failure.Vv ecmo was performed using avalon double lumen catheter and quadrox id pediatric with tubing set ((b)(4)).After initial of vv ecmo, patient blood gas, pre/post membrane blood gas was checked and revealed the post membrane po2 108 mmhg (with fio2 1.0, while pco2 was in normal range.Perfusionist double check the connection of gas line , changing the gas blender , check the leakage of gas pipe line.Alls are secure and no abnormal was detect, then the 2nd post membrane blood gas was repeated and still revealed slightly low at 114.7 mmhg.Customer suspect sign of membrane oxygenator failure.The cardiac surgeon and perfusionist decided to change the circuit with new quadrox id and repeat blood gas after circuit change revealed post membrane oxy po2 at 633 mmhg.With fio2 1.0.No abnormal of patient condition were noted (b)(4).

Manufacturer Narrative

The returned product was investigated at the laboratory of the manufacturer.During visual inspection clots were noted at the blood inlet and blood outlet side.To ensure performance of the products prior to shipment, checks, controls, and performance tests are carried out during the manufacture of the products.These tests can be reviewed as part of a dhr review.There were no references found, which are indicating a nonconformance of the product in question.Additionally a review of the weekly performance monitoring according to si-c-09 has been reviewed, the performance tests passed the acceptance criteria.Based on the results obtained during investigation at this time the cause of the reported incident was determined to not be attributed to a device related malfunction.Thus the reported failure could not 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: 6744031
• MDR Text Key: 81501658
• Report Number: 8010762-2017-00247
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K100278
• 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: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2017
• Device Model Number: BE-HMOD 30000
• Device Catalogue Number: 701047041
• Device Lot Number: 7010679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2017
• Date Device Manufactured: 08/01/2015
• 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