MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HEATER-COOLER UNIT HCU 40 HIGH VOLTAGE; HEAT-EXCHANGER, CARDIOPULMONARY BYPASS

Model Number HCU 40 HIGH VOLTAGE

Device Problems Leak/Splash (1354); Device Emits Odor (1425); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 02/01/2019

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 stated that when startup of device the hcu40 unit, a vacuum valve was leaking, causing pop noise and burning smell before it triggered the mains supply.No patient was involved.Internal reference: (b)(4).

Event Description

Internal reference: (b)(4).

Manufacturer Narrative

A getinge service technician has been sent over for investigation on 2019-03-11, where the failure was serviced and detected.The vacuum valve and the main board were replaced.The technician confirmed that functional tests has been performed and found ok.The device is back in clinical use.A life cycle engineering (lce) investigation was performed in order to determine the root cause of the reported issue.According to lce investigation report# (b)(4) following was found: the lce performed visual,electrical and mechanical tests.It was complained, that the vacuum valve was leaking.This could be confirmed, but not reproduced.A cause for the leakage could not be identified.Additionally, it was mentioned that the device board had been destroyed by a fluid.This can be confirmed, too.It is plausible that the fluid caused a short circuit on the pcb, which then triggered the complained burning smell and the fuse.Unusually, it was noticed that the drip protection at the housing of the pcb was not present.Reason not found.Thus the failure could be confirmed.The device was part of fsca-2018-07-18, in which the vacuum valve was replaced on 2018-11-26.This supports the above findings of the technician, that the leaking of the valve could be confirmed but not reproduced.The most probable root cause could be determined by fluid that got on the device board.There was a short circuit on the board, which destroyed the board.This also explains the complaint about the smell of fire and the triggering of the fuse.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.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: maquet medical systems usa 45 barbour pond drive wayne, nj 07470.Contact person: (b)(4).

• Brand Name: HEATER-COOLER UNIT HCU 40 HIGH VOLTAGE
• Type of Device: HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 8370589
• MDR Text Key: 139062752
• Report Number: 8010762-2019-00047
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• PMA/PMN Number: K130300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HCU 40 HIGH VOLTAGE
• Device Catalogue Number: 70104.4054
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1