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

Model Number BO-VKMO 71000

Device Problem Output below Specifications (3004)

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

Event Date 08/20/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the hospital: "massive decrease in oxygenator performance (po2 20mmhg at 100% oxygenation).After oxy change, op could be completed without further complications.Oxygenator had to be changed after approx.2.5 hours".(b)(4).

Event Description

Ref#: (b)(4).Customer ref: (b)(4).

Manufacturer Narrative

Maquet medical systems, usa (importer) submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption#: (b)(4).Importer:maquet medical systems usa 45 barbour pond drive wayne, nj 07470.Contact person: (b)(4).Product was needed for investigation in the laboratory of manufacturer.It was requested on 2018-10-30 and received on 2018-11-23.However declaration of infection risk form was not received.It was requested respectively on 2018-11-23, 2018-11-28, 2018-12-05.No doir was received.Since the package of the product cannot be opened and investigated, the confirmation of this complaint is not possible.The contribution of product to the failure could not be identified.Also the serial number on the oxygenator cannot be read since it cannot be opened.Therefore no meaningful dhr review could be performed.Sap trend search was performed (product group 31000 & 56000, failure code 0306 oxygenation) which came to following results:12 additional complaints were recorded which appears reported issues are the same since the last 12 months.However 10 complaints are in status of 'not confirmed'.Based on the sales figures of the last 12 months following occurrence rate has been calculated: (b)(4), which is below than (b)(4).Due to this information no systemic issue could be determined.This complaint now will be closed.If any information becomes available which helps to determine the root cause, it will be reopened.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.

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7881477
• MDR Text Key: 120538108
• Report Number: 8010762-2018-00260
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K102532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2020
• Device Model Number: BO-VKMO 71000
• Device Catalogue Number: 701067951
• Device Lot Number: 92250795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2018
• Date Manufacturer Received: 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention