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

Model Number HMO 51000-J

Device Problems Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964)

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

Event Date 08/31/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device was requested but not received a follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the customer: "procedure: taa+open stent grafting.During the extra corporeal circulation, the customer noticed some abnormalities on the pco2 and po2 soon after the circulation stopped and restarted.After restarted the circulation, the customer increased the o2 flow to 2.00ml/min and the fio2 to 80%; however, there was no improvement.They kept increasing both.The customer performed the assisted circulation for about 1.5 hours as increasing the o2 flow and the fio2 after aodeclamp and the extracorporeal circulation was finished." (b)(4).

Manufacturer Narrative

The product was visually inspected in the laboratory of the manufacturer.On the blood inlet and outlet side no clots were detected.The product was cleaned with sodium hypochlorite solution.No other abnormalities were detected.Affected product: basic lot 70111611 and packaging lot 70112506 (serial number (b)(4)).The avz 7513 from (b)(4) was reviewed on 2017-10-23.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 (dms# (b)(4)), the performance tests passed the acceptance criteria.Thus 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.

Event Description

Ref.: # 703006496, customer ref.: 17-0760.

• 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: 6875684
• MDR Text Key: 87633137
• Report Number: 8010762-2017-00306
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K090689
• 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: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2017
• Device Model Number: HMO 51000-J
• Device Catalogue Number: 701048782
• Device Lot Number: 70112506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2017
• Date Device Manufactured: 06/01/2016
• 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