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

Model Number 70104.4054

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Excessive Cooling (2932)

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

Event Date 01/07/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the customer: it was reported that the tank was frozen.Additional information: the incident occurred during patient treatment.Ref.: (b)(4).Customer ref.: n/i.

Event Description

Ref.:(b)(4).

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.Importer- (b)(4).Contact person- (b)(6).As the customer had problems with ice building for a long time, a service technician from our technical support team was on site.The device was inspected and the water quality was checked.It was found that the customer was adding sodium chloride to the water, which affects water conductivity.In the geelong area in australia, the mineral composition of the used tap water in the (b)(6) hospital together with sodium chloride changes the mineral composition of the water significantly.That means even if there is a large ice block in one tank section, it could be that a low ice sensor value is displayed.The reason behind this is the physically changed molecular structure of the ice blocks.There are many micro-tunnels within the ice blocks, where the water is still going through.This water has an electrical high conductivity.Therefore the ice sensor detects water and because of that the compressor keeps working to build ice.This results in a tank freezing.The customer was advised on how to avoid this problem in the future.According to the on-site visit final report: with adding sodium chloride, the electrical conductivity of water increases and the molecular structure of the water changes.This has an impact on the ice detection.Thus the failure could not be confirmed.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.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.

• Brand Name: MAQUET HCU40 DEVICE
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 8264695
• MDR Text Key: 133837169
• Report Number: 8010762-2019-00015
• 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
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2019
• 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?: No
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1