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

Model Number HMO 51000-J

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product was requested but not yet received.The investigation of the manufacturer is still pending.A supplemental medwatch will be submitted when additional information becomes available.

Event Description

According to the customer: "during the procedure, the customer found that the gas exchange was not being done properly.Tried turning up the flow or fio2 and the problem was fixed temporarily, but pao2 came down immediately." -no adverse effects on the patient.-occurred during patient use.(b)(4).

Manufacturer Narrative

The product was visually inspected in the lab.No abnormalities were detected, the product was delivered already cleaned.The product was tested for its o2 and co2 transfer rate at maximum blood flow as well as pressure drop at maximum flow with bovine blood.The product was operating within the acceptance criteria's and therefore passed the test run.No abnormalities were detected; the product was operating within its specifications.Thus the reported failure could not be confirmed.The cause of this failure was determined to not be attributed to a device related malfunction.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: 6132185
• MDR Text Key: 61404596
• Report Number: 8010762-2016-00698
• 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: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2018
• Device Model Number: HMO 51000-J
• Device Catalogue Number: 701048782
• Device Lot Number: 70109135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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