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

Model Number HQV 85500

Device Problems Leak/Splash (1354); Increase in Pressure (1491); Improper or Incorrect Procedure or Method (2017); Material Deformation (2976)

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

Event Date 02/13/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

(b)(4) replaced the duck-bill valves and replaced them with one-way valves in our recirculation lines.This morning during a case the aortic line got kinked at the operating table so the pressure in this line went high momentarily.However, during this brief period there was enough pressure built up to force blood through the small holes in the one way valve.The pressure went above 300.The kink was in the tubing attached to the valve.The kink was caused by the surgical team during the operation.This resulted in the valve being overpressurised and blood leaking out the top.Ref.: (b)(4).

Event Description

Ref.: # (b)(4).

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.Importer- maquet medical systems usa, 45 barbour pond drive, wayne, nj 07470.Contact person- (b)(6).Maquet cardiopulmonary gmbh was investigated the product in the laboratory of manufacturer.The sample only received with the short tubes on each side of the valve.At the outlet of the oneway valve, the tube is slightly bent.Blood can be seen under the tube at the mold partitions of the connector.On tube, oblique imprints can be seen at the cable tie.Leak test was performed at approximately 0,3 bar pressure.A leak under the cap (drawing position 7) was detected.Getince cp antalya reviewed device history record of the complained batch.In addition, supplier reviewed device history record of the valve.There were no references found which are indicating a non-conformance of the product in question.According to supplier, during manufacturing the valves undergo 100% inspection for leak.Dhr of the valve shows no abnormality.However it was decided that sample investigation is needed.Based on that supplier complaint has been initiated for further investigation of this issue.Therefore, one of the most probable cause could be material failure.The other cause could be operational issues as stated in the initial report.Getinge cp antalya has initiated scar # (b)(4).All further actions will be followed by this scar.The reported failure did not contribute to death or serious injury.In addition at this time it cannot be concluded that this is a systemic error.No further actions in the field are required.This complaint is being monitored as part of the complaint data trending of maquet cardiopulmonary gmbh and further investigations and measures will be conducted in case of adverse trending.

• Brand Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 8373865
• MDR Text Key: 141248747
• Report Number: 8010762-2019-00055
• 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: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/23/2020
• Device Model Number: HQV 85500
• Device Catalogue Number: 701052272
• Device Lot Number: 92245576
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1