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

Model Number 701044054

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).A maquet field service technician has been sent out for investigation on 2019-03-06 and found a defective flow sensor.The technician replaced the old type of flow sensors on both circuits (patient and cardioplegia circuit) with the new type of flow sensors as there is a fsca (fsca-2018-11-19) which resulted out of a capa.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this capa-(b)(4) has been opened.

Event Description

It was reported that the hcu40 flow sensor was defective and the customer couldn't bleed the hoses.The incident occurred prior to use but the patient was already under anesthesia.Therefore a replacement device was brought into the theatre.Additional information: there were no negative consequences for 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): 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: 8432827
• MDR Text Key: 142641942
• Report Number: 8010762-2019-00074
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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
• Report Date: 03/19/2019

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 Model Number: 701044054
• Device Catalogue Number: 701044054
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2019
• Initial Date FDA Received: 03/19/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2017
• 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