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

Model Number BEQ-HMOD30000-USA#Q

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombus (2101)

Event Date 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Clotting was noted on the arterial outlet side of the hmod 30000 during use.Upon inspection of the clot it warranted the customer to change out the oxygenator.No harm to the patient was reported.(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).Maquet cardiopulmonary gmbh requested the product for investigation.The oxygenator was investigated in the manufacturer laboratory on(b)(6)2018: a quadrox id pediatric was returned.Oxygenator was contaminated.Oxygenator cleaned with sodium hypochlorite.Visual inspection performed.Original tubes on the connectors were left out.Error pictorial documented.The blood outlet connector is damaged.The edge of the connector is inside pressed in and thereby may be at the site of a clot between the tube and connector.In addition, a leak test was performed.A leak could not be determined.No further abnormalities could be detected.The probable root cause of the reported failure could be determined to the damage of the connector.Thus the failure could be confirmed.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.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

Internal reference:(b)(4).

• Brand Name: OXYGENTOR, CARDIOPULMONARY BYPASS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7450860
• MDR Text Key: 106388240
• Report Number: 8010762-2018-00148
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K100278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2018
• Device Model Number: BEQ-HMOD30000-USA#Q
• Device Catalogue Number: 701050330
• Device Lot Number: 70110923
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1