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

Model Number HMO 71000 J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 08/09/2017

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).The device has been requested but not received.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the customer: "two hours after the extracorporal circulation started at the cabg surgery, pa02 decreased to 130mmhg.The customer operated to increase fi02 from 65% to 70%, so that p02 increased to 266mmhg in the end.Stayed on the same device and continued the procedure.1 hour later, pa02 decreased again to 119mmhg before weaning, and p02 did not go up any more even if fi02 was adjusted 100%.The customer continued to use the device and the surgery was finished without any problem".No adverse effects on the patient (b)(4).

Manufacturer Narrative

The product was visually inspected in the laboratory of the manufacturer.No clots were detected.The product was cleaned with sodium hypochlorite solution.No other abnormalities were detected.Affected product: basic lot 70113492 and packaging lot 70115550 (serial number (b)(4).The avz from geq 300 to geq 314 (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.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

(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: 6816973
• MDR Text Key: 83745853
• Report Number: 8010762-2017-00274
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2017

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: 01/01/2015
• Device Model Number: HMO 71000 J
• Device Catalogue Number: 701048762
• Device Lot Number: 70115446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2017
• Initial Date FDA Received: 08/24/2017
• Supplement Dates Manufacturer Received: 10/27/2017
• Supplement Dates FDA Received: 10/27/2017
• Date Device Manufactured: 01/01/2017
• 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