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

Device Problems Arcing (2583); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

A life cycle engineering (lce) investigation was performed in order to determine the root cause of the reported issue.According to lce investigation report following was found: after the removal of the power supply, large crystalline deposits were found below it.The characteristics of the liquid distribution, particularly in the area of the power supply unit, suggest that this was the cause of the error formation.Thus the failure could be confirmed.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

(b)(4).

Manufacturer Narrative

Send again as follow up emdr.The emdr (b)(4) was sent out as not follow up emdr by mistake.A life cycle engineering (lce) investigation was performed in order to determine the root cause of the reported issue.According to lce investigation report following was found: after the removal of the power supply, large crystalline deposits were found below it.The characteristics of the liquid distribution, particularly in the area of the power supply unit, suggest that this was the cause of the error formation.Thus the failure could be confirmed.The occurrence rate of this failure is below the acceptance limit.Therefore, no remedial action required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

(b)(4).

Manufacturer Narrative

This report is a duplicate of #(b)(4) / mfg report # 8010762-2019-00134 and further information is available there.

Event Description

It was reported that the hcu 40 power control board was noisy and arcing.The incident occurred during service, so there was no patient involved or could be harmed.(b)(4).

• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): NURSEL BOELENS; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; 4972229321
• MDR Report Key: 9155040
• MDR Text Key: 174864679
• Report Number: 8010762-2019-00315
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 10/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1