MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEATER - COOLER UNIT HCU 40; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Catalog Number 701044054

Device Problem Arcing (2583)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

A maquet field service technician investigated the device in question.A defective power control board (pcb) was found and replaced.A full diagnosis check was carried out and the device was checked as per service manual.All tests passed and no safety or function defects were detected.The manufacturer requested the defective pcb for further investigation.(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

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).

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 reported failure "power control board nosiy and arcing" 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 cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.We have now submitted a follow up report with updated information for this report, instead of the 8010762-2019-00315 report you suggested.The reasoning behind us doing so is the following: we received a customer product complaint (#(b)(4)) from the uk market about a hcu40 product and reported it with this report, our initial emdr #213910.A few errors occurred in sequence, at our side, that caused a duplication of reports; error #1: a follow up report was intended to be sent with our emdr #254273.Due to human error this file was raised as initial by mistake.As a result our system allocated a new emdr number to it: 8010762-2019-00315.As a result the file was sent with many fields blank as would be usual for a follow-up report but of course not correct for an initial report.This is why you found the event and codes blocks as blank.Error #2: a follow up report was then sent on 8010762-2019-00315.Since it was a follow-up report nobody thought to update the blank blocks.In conclusion report 8010762-2019-00315 are duplicate reports for the same event.We now intend to: add to the manufacturer narrative of our latest the explanation as per previous points.Write in the 8010762-2019-00315 report that the report is a duplicate of this report and further information is available here.

Event Description

Internal reference number: (b)(4).

• Brand Name: HEATER - COOLER UNIT HCU 40
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 8639986
• MDR Text Key: 146063112
• Report Number: 8010762-2019-00134
• 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,o
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 701044054
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1