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

Model Number 701044054

Device Problems Fluid/Blood 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).

• Brand Name: MAQUET HCU 40
• 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: 8597213
• MDR Text Key: 144985557
• Report Number: 8010762-2019-00123
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K130300
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2019
• Initial Date FDA Received: 05/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention