MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG TUBING,PUMP, CARDIOPULMONARY BYPASS; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number BE-HQV 34708

Device Problem Leak/Splash (1354)

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

Event Date 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Hospital noticed during patient use a leakage on the one way valve on the red line.(b)(4).

Manufacturer Narrative

The sample has not been returned to maquet for investigation in our laboratory.However, there is a picture related to the complaint.The investigation of the received picture showed that the leakage of the suction valve.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 ag is aware of similar complaints from this product.Similar products, showing a similar malfunction, have been investigated in #(b)(4).; ¿'the function of received suction valve,which was cut out of the tube set by customer, was tested with water.When the correct flow direction was provided,the water flows through the valve withoutleaking.Then,the function of the valve was checked with water in the wrong direction.It immediately leads to a leak at the top of the cap.A leak can not be confirmed in this case.The valve was worked within specifications'' based on this, complaint could not be confirmed.Sap trend search was performed (product group 31000 cts, failure code: 0114 other tube set components-leakage) which came to following results: 5 additional complaints were recorded which appears reported issues are the same since the last 12 months.4 complaints are in status 'not confirmed'.Based on the sales figures of the last 12 months following occurrence rate has been calculated: 0,2%, which is below than 1%.Due to this information no syste mic issue could be determined.Device history record of the complained lot was reviewed.There were no references found which are indicating a nonconformance of the product inquestion.Also, there is no nonconformity and no scar related to the claimed material.

Event Description

Ref.(b)(4).

• Brand Name: TUBING,PUMP, CARDIOPULMONARY BYPASS
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 8244202
• MDR Text Key: 133189301
• Report Number: 8010762-2019-00007
• 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: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2020
• Device Model Number: BE-HQV 34708
• Device Catalogue Number: 701064517
• Device Lot Number: 92238639
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 01/14/2019
• Supplement Dates Manufacturer Received: 02/15/2019
• Supplement Dates FDA Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1