MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number HQV 51201

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Death (1802)

Event Date 08/22/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

The incident was reported by user to (b)(6).According to the (b)(6) report: "details of injury (to patient, carer or healthcare professional): stroke following coronary artery bypass grafts followed by death 4 months later.(b)(6) suggested microemboli as a possible cause linked to artificial surface of cardiopulmonary bypass circuit.'' ref.: # (b)(4).

Event Description

Ref: (b)(4).

Manufacturer Narrative

(b)(4).This incident was not reported to maquet ltd.Sales or qa departments by customer.The hospital reported the case directly to the authority.Maquet caridopulmonary gmbh was received this reporting information on 2019-03-14 and initiated this complaint.Device history record was reviewed.There were no references found which are indicating a non-conformance of the product in question.During investigation, information was received from maquet ltd.Product manager, sales that the case went completely normally, the product functioned as per expectation.The cause of the reported event was determined to not be attributed to a device related malfunction.Based on these results and the information available at this time the set in question operated within mcp specifications.2019-04-11.Thus the reported failure could not be confirmed.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: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 8474889
• MDR Text Key: 140666230
• Report Number: 8010762-2019-00089
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K053025
• 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: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HQV 51201
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death