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

Model Number HMO 71000

Device Problem Pressure Problem (3012)

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

Event Date 10/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the customer: "15 min after the start of the heart-lung machine sudden delta p rise above 200mmhg.Measured pressure before oxy 400mmhg, measured pressure according to oxy 180mmhg.Pao2 drop from 240mmhg to 130mmhg.Act during the event always over 430 acute change of the oxygenator (emergency situation), aterial mean pressure of the patient during the oxygenator change to 30 mmhg, no long-term sequences visible to the patient." ref.: #(b)(4).

Manufacturer Narrative

The product was visually inspected in the laboratory of the manufacturer.On the blood inlet and blood outlet side no clots were detected.During rinsing no clots were flushed out.The product was cleaned with sodium hypochlorite solution.No other abnormalities were detected.Dhr review: affected product: basic lot 70115732 and packaging lot 70115696 (serial number (b)(4).The avz from gkv 820 to gkv 834 (b)(4) was reviewed on (b)(6) 2017.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 (b)(4), the performance tests passed the acceptance criteria.The reported failure could not be confirmed.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 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: 7004010
• MDR Text Key: 92201004
• Report Number: 8010762-2017-00354
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: HMO 71000
• Device Catalogue Number: 701067822
• Device Lot Number: 7011696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2017
• Initial Date FDA Received: 11/06/2017
• Supplement Dates Manufacturer Received: 12/12/2017
• Supplement Dates FDA Received: 12/14/2017
• Date Device Manufactured: 02/01/2017
• 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