MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HCU40 DEVICE; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 70104.4054

Device Problems Failure to Prime (1492); Improper Flow or Infusion (2954)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(6) 2015 01:13 pm (gmt-4:00) added by (b)(6) ((b)(4)): (b)(4), usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag (b)(4).A maquet field service technician will investigate the unit.A supplemental medwatch will be submitted when additional information becomes available.

Event Description

It was reported the hcu40 exhibited problems during the de-airing --> fault are "pat.: water flow low" and after some seconds "water flow too low".No patient was involved the malfunction occurred during priming / setup.(b)(4).

Manufacturer Narrative

(b)(4).A maquet field service technician was on site and investigated the unit in question.The technician confirmed the error message "no flow on patient side".The technician performed the following work on the unit: performed leakage test.Replaced a defective flow sensor on the main side of the unit.Replaced a defective shunt valve on the main side of the unit.Cleaned the shunt valve on the cardioplegia side of the unit.Performed disinfection with clorina.The unit was tested according to the service protocol, all tests were performed successfully.The unit was returned to service.The manufacturer requested the replaced parts back for a root cause analysis.A supplemental medwatch will be submitted as soon as the investigation results becomes available.

Event Description

(b)(4).

Manufacturer Narrative

The manufacturer investigated the defective parts of the hcu40 (flow sensor and shunt valve).The investigation results are the following: investigation results of the flow sensor: the flow sensor was tested with a hcu40 unit from maquet.The patient-water circuit showed a flow of 15.2 lpm and the cardioplegia water cycle displayed a flow of 15.0 lpm.The flow sensor ran for several hours without any abnormalities.The next day, the flow sensor was connected again to the patient-water circuit.This time the unit displayed a flow of 15.1 lpm and the cardioplegia water circuit showed a flow of 0.0 lpm.After about 5 minutes the flow sensor showed suddenly 15.1 lpm at the cardioplegia water circuit.The measuring tube of the flow sensor is bonded to two thin measuring cables to the housing.When during screwing the connection pipe of the hcu40 to the flow sensor housing, a slight movement between the measuring tube and the flow sensor housing arise, the measuring cables can tear.The result is a loose connection through to loss of function.Probable root cause: the flow sensor is very sensitive during assembly.A slight movement between the measuring tube and the housing can lead to the destruction of the measurement electronics.A "service instruction heater-cooler unit hcu 40 flow sensor replacement" was provided from the manufacturer.This service instruction is made specifically aware of the proper handling of the flow sensor (see below the notice from the service instruction on page 7 - "main flow sensor installation"): "the pipe connection on the sensor housing is of plastic and can be damaged if the cap nut does not come straight on the thread.If the thread is damaged the sensor will become unusable.The torque applied to the cap nuts on the sensor pipe connections must be 5 nm.Excessive torque will break the sensor mechanism or cause leakage.Insufficient torque will cause leakage." investigation results of the shunt valve in question: first a visual check was performed and the seal of the housing was removed and the shunt valve was dismantled.The anchor had significant traces of rust on the shaft and on the front side.Also the pressure spring on the front side as well as the magnet were rusted.The problem of the shunt valve is known by our r & d and preventive actions are currently being prepared.Probable root cause: the rust on the shunt valve lead to stiffness of the anchor of the shunt valve.The expected time frame for the start of the production for the improved shunt valves is at the beginning of may 2016.

Event Description

(b)(4).

• Brand Name: MAQUET HCU40 DEVICE
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; 4972229321
• MDR Report Key: 5032548
• MDR Text Key: 25010108
• Report Number: 8010762-2015-01018
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K130300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup,Followup
• Report Date: 07/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70104.4054
• Device Catalogue Number: 70104.4054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1