MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH MAQUET HCU 40; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 701044054

Device Problems Leak/Splash (1354); Material Rupture (1546)

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

Event Date 04/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A maquet field service technician has been sent out for investigation on 2019-04-16.The technician troubleshooted the device and could confirm that the hose from the reservoir to the 3-way valve is attacked and damaged by disinfection and decalcification.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.According to the service order (b)(4) dated on 2019-04-23: date: 2019-04-16: checked the hcu40.Water flows out of the device on the patient side.Search for leakage.The hose from the reservoir to the 3-way valve is damaged and torn by disinfection and decalcification.The hose must be replaced.The incident occurred on (b)(6) 2019 during surgery.There was no injury to the patient, the surgery could be continued after immediate replacement of the hcu40.Date: 2019-04-23: replacement of the defective hose.Hose insulated with armaflex, device fully tested for function and tightness.Diagnostic program has run successfully and without error.Hcu40, sn: (b)(4) is ready for use again.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.

Event Description

It was reported that the hcu had a rupture in the hose that led to a leakage.The incident occurred during patient treatment and the surgery could be continued immediately after the replacement of the device.There was no injury or negative consequences to the patient.(b)(4).

• Brand Name: MAQUET HCU 40
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): NURSEL BOELENS; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; 4972229321
• MDR Report Key: 8577638
• MDR Text Key: 144984049
• Report Number: 8010762-2019-00115
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K130300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701044054
• Device Catalogue Number: 701044054
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention