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U.S. Department of Health and Human Services

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

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MAQUET CARDIOPULMONARY GMBH MAQUET HCU 40 CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 701044054
Device Problems Fluid Leak (1250); Leak/Splash (1354); Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/23/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). On 2019-04-24 a maquet field service technician (fst) was on site and investigated the unit in question. The fst could confirm that the device pcb was damaged due to a leaky flow sensor (old type) which dripped water on the pcb. 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 (b)(4) dated 2019-04-24: unit reported to smell like smoke and spark during a case. Unit was swapped and case was finished. Completed fsca 2018-11-19. Leak was coming from connection of old style flow sensor and cardio wet end kit, replaced wet end kit, this leak had dripped onto the device board causing a short and the smoke smell. Device pcb badly damaged. Replaced device pcb. Unit was due for servicing. Replaced filter mat and uv lamp with pass through system. Leak test was completed - no leaks detected. Completed inspection. Visual check - pass. Electrical safety - pass. Function tests - pass. Measured value and alarm monitoring - pass. Passed all functional tests. 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

It was reported that the hcu40 smelled like smoke and sparked during use. The device was replaced during treatment. There were no negative consequences to the patient. (b)(4).

 
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Brand NameMAQUET HCU 40
Type of DeviceCONTROLLER, 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 Key8597213
MDR Text Key144985557
Report Number8010762-2019-00123
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK130300
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 05/09/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/09/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number701044054
Device Catalogue Number701044054
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/01/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 05/09/2019 Patient Sequence Number: 1
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