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

Model Number 701044054

Device Problems Insufficient Flow or Under Infusion (2182); Device Displays Incorrect Message (2591)

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

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 hcu 40 had a low flow error on the cardioplegia side.This incident occurred on start up of the device.(b)(4).

Manufacturer Narrative

(b)(4).The initial medwatch, which was sent to the fda, was incorrectly evaluated to be reportable.The reported issue was incorrectly assessed to be "pat.Water pressure too high".This is reportable, however, the correct assessment should have been "leakage at the bottom of the device" which is not reportable.This reported issue is also a continuation of a previous complaint which was not reportable.During the investigation, the origin of the leakage was identified.The relevant parts were replaced and the device was deemed fit for purpose.This follow up medwatch was generated to inform the fda that the initial medwatch was raised in error.This follow up report also serves as a final notification to this issue.

Event Description

(b)(4).

• Brand Name: MAQUET HCU 40
• 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: 6083393
• MDR Text Key: 59605653
• Report Number: 8010762-2016-00660
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Type of Report: Initial,Followup
• Report Date: 06/29/2017

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?: No
• Initial Date Manufacturer Received: 10/17/2016
• Initial Date FDA Received: 11/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2017
• Date Device Manufactured: 05/01/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1