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

Model Number HMO 71000-J

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the customer: "during the patient use, about 120 - 130min.After the extracorporeal circulation started, gas exchange ability decreased.Although they tried flashing, there was no improvement, so the customer replaced the oxygenator.However, the similar symptom also occurred to the replaced device.The customer continued to use the replaced device because it was closed to weaning.The surgery finished successfully." no adverse effects on the patient.(b)(4).

Manufacturer Narrative

The product was investigated in the laboratory of the manufacturer.A visual inspection was performed.The product was very dirty from the outside.The oxygenator was cleaned with sodium hypochlorite solution.No other abnormalities were detected.Affected product: basic lot 70114748 and packaging lot 70115447 (serial number (b)(4).The avz from gvg 530 to gvg 544 (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: 6875784
• MDR Text Key: 87356978
• Report Number: 8010762-2017-00307
• 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: 10/25/2017

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: 01/01/2019
• Device Model Number: HMO 71000-J
• Device Catalogue Number: 70104.8762
• Device Lot Number: 70115445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2017
• Initial Date FDA Received: 09/19/2017
• Supplement Dates Manufacturer Received: 10/20/2017
• Supplement Dates FDA Received: 10/25/2017
• 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