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

Model Number BO-HQV 67302

Device Problem Insufficient Flow or Under Infusion (2182)

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

Event Date 02/03/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the hospital: "the oxygenator worked first 2 hours, but the capacity of oxygenating blood decreased a lot even if oxygen was set 100%.Blood gas analysis was done and this was confirmed that the oxygenation was not adequate.No reason was detected so they suspect that the problem was the oxygenator.No replacement of the oxygenator was done.After procedure patient's blood values normalized after 3.5 hours in respirator." (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).Rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).Importer- maquet medical systems usa (b)(4).Contact person- (b)(6).A trend search has been performed on(b)(6)2018 (search for material number 70107.0505, issue: oxygenation) which came to following results: no other complaints were recorded since the last 12 months.Based on the recent sales numbers of the last 12 months following occurrence rate has been calculated:(b)(4).Thus the occurrence rate is below 1% - due to this information no systemic issue could be determined.The sample has been cleaned and inspected visually.Further investigation steps are momentarily not possible to be executed due to work safety issues in the complaint laboratory.Maquet cardiopulmonary is currently in the mitigation of this issue.When further investigation steps can be executed again, these investigations will be performed and the complaint file will be updated accordingly.Thus the reported failure could not be confirmed.Thus the most probable cause could be not determined at this time.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.Dhr review result: affected product: basic lot 70116260 and packaging lot 70116370 (serial number (b)(4).The avz from exg580 to exg594 (dms# 2383749) was reviewed on(b)(6)2018.There were no references found, which are indicating a nonconformance of the product in question.

Event Description

Ref.: #703006732, customer ref.: (b)(4).

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7306278
• MDR Text Key: 101502945
• Report Number: 8010762-2018-00076
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K082117
• 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: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2019
• Device Model Number: BO-HQV 67302
• Device Catalogue Number: 701070505
• Device Lot Number: 92220265
• Date Manufacturer Received: 10/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention