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

Model Number 701044054

Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

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

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the customer: at the end of a valve replacement case, emptying the tubes of a hcu40 was performed twice.When the tubes were disconnected, water ran out of the tubes and appeared under pressure.The water from the hcu reached the patient and drapes.Big concern of contamination.Last water samples were taken in september and did not show any evidence of mycobacterial contamination.Additional information: the incident occurred during patient treatment.(b)(4).

Manufacturer Narrative

A maquet field service technician was on site and investigated the unit in question.The technician ran successfully a diagnostic test.The device was also tested successfully for comprehensive.The service protocol from the last pm had no anomalies.The device worked within its specification.A supplemental medwatch will be submitted if additional information becomes available.

Event Description

(b)(4).

Manufacturer Narrative

Maquet medical systems,usa (importer) submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption#: e2018002.Importer: (b)(4).Contact person: (b)(6).Correction: it was noted that during an internal review the aware date on the draft initial mw from the factory was 12/06/2017; whereas the aware date noted on the initial trackwise submission was 07/01/2016.This is a typo error on behalf of the ssu.

Event Description

Ref: (b)(4).

• Brand Name: MAQUET HCU40 DEVICE
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7143345
• MDR Text Key: 95915595
• Report Number: 8010762-2017-00409
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K130300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• 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
• Date Manufacturer Received: 12/06/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1