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

Model Number 701044054

Device Problems Loss of Power (1475); Infusion or Flow Problem (2964)

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

Event Date 09/07/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the hcu40 had a "water flow too low" occurred during patient treatment.Water pump of patient circuit stopped.There was a medical intervention necessary.So they have to exchange the device.No harm to the patient was reported.(b)(4).

Manufacturer Narrative

A field service technician was on site and investigated the unit in question.The technician troubleshooted the device and found a defective flow sensor.Thus the failure could be confirmed.A nc was opened for the issue "low flow" and "flow too low" to investigate the malfunction of the flow sensor which led to these error messages.The investigation and probable root cause determination will be handled via nc-17-05-005 dms-#2386632.The documentation of all following investigation outcomes will be done in sap complaint (b)(4).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: the technician replaced the flow sensor.No error.The device working properly.

Event Description

Ref.: # (b)(4).Customer ref.: one support# (b)(4).

Manufacturer Narrative

According to the technician (b)(6): the incident occurred during patient treatment.The device was exchanged but there was no delay in surgery and no negative consequences for the patient.According to the service order: the technician replaced the defective flow sensor.

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 ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 6917440
• MDR Text Key: 89697401
• Report Number: 8010762-2017-00314
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K130300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• 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: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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