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

Model Number 701044054

Device Problems Circuit Failure (1089); Electrical /Electronic Property Problem (1198); Device Emits Odor (1425); Electrical Shorting (2926)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 04/02/2019

Event Type  malfunction  

Manufacturer Narrative

(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 left overnight to build ice.During priming / setup for use the customer smelled the smell of electrical burn.The system was replaced and taken out of service for further investigation.Additional information: the replacement of the device caused no delay for the surgery and no known negative consequences for the patient was stated.(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).Rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).Importer- maquet medical systems usa (b)(4).Contact person- (b)(6).On (b)(6)2019 a maquet field service technician was on site and investigated the unit in question.The technician troubleshooted the device and found that some electrical components on the driver circuit board were defective and the board needs to be replaced.The defective part was requested on (b)(6)2019 for further investigation.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.According to the service report 42967818 dated (b)(6)2019: (b)(6)2019: check system as customer has reported smelling something electrical melting.Could not see anything obvious so started to turn on electrical components one by one.When starting up the clpg pump, there was a flash and an electrical smell.A closer look found that the faulty water pump has taken out some electrical components on the driver circuit board.2019-04-18: travel to the office first to pick up the required parts.Carry out the replacement of the failed parts.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.

Event Description

Internal reference: (b)(4).Customer reference:(b)(4).

Manufacturer Narrative

The defective part was investigated by our lifecycle engineering.According to the lce investigation report dated on 2019-11-14: on the device printed circuit board were dried liquid residues from the clorina cleaning agent.These form a conductive connection between two pins on connector x1 of the control unit.This causes a short circuit and the actuators of the peripherals are affected in their function or fail completely.In this case the clpg pump was affected.Conclusion: the most probable cause of the fault is liquid residue from the clorina detergent which causes short circuits and this influences the actuators, such as the pump or the heater.Thus the failure could be confirmed.

Event Description

Internal reference: (b)(4).Customer reference: (b)(4).

• Brand Name: MAQUET HCU 40
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 8528607
• MDR Text Key: 142775568
• Report Number: 8010762-2019-00104
• 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: 12/02/2019

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/02/2019
• Initial Date FDA Received: 04/18/2019
• Supplement Dates Manufacturer Received: 05/22/2019; 05/22/2019
• Supplement Dates FDA Received: 05/22/2019; 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1