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

Model Number 70104.4054

Device Problems Break (1069); Device Emits Odor (1425); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The unit has been investigated by the maquet life cycle engineering department.A visual inspection has been performed.The housing of the unit was removed and damages due to overheating on the mains plug and on the plug contact at the mains filter were detected.Also the thermal insulation of the bend and of the piping on the main side of the unit was defective.Furthermore water spots were found on different locations inside the unit.Since traces of water could be seen on the e-box, the e-box was dismantled to investigate the device pcb accurately.In the e-box and on the board on both sides visible water stains could be confirmed.Moreover at a connection of the lambda-power supply, on the device pcb a damage due to?? overheating was detected.During further investigation the switch on relay was found burned.In this case, the device in question draw too much power and due to the power overload the switch on relay of the transformer was burned.The mains plug and the connection of the mains filter show traces of overheating.Also on the device pcb is a damage due to overheating at the mains adapter recognizable.The power overload that caused the overheating of the components was most likely caused by the water inside the units housing.A root cause for the water leakage could not yet be confirmed during the investigation.It is not clear yet whether the device will be repaired.After this decision will be taken by the customer a final (b)(4) report will be submitted.

Event Description

"suddenly during the operation, there was a bang and the main fuse of the operating theatre blew.The customer took the hcu40 out of the operating theatre and brought it to the perfusionist room.When starting the hcu40 in the room, the main fuse of the room was blowing a few seconds after switching on the device.A burning smell was localized." unit was replaced during surgery no delay of the surgery.No negative consequences for the patient.

Manufacturer Narrative

The customer decided not to repair the device.The device was not returned to the customer.

Event Description

(b)(4).

• Brand Name: MAQUET HCU 40 DEVICE
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MICHAEL CAMPBELL; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437
• MDR Report Key: 5154487
• MDR Text Key: 28443029
• Report Number: 8010762-2015-01106
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K130300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 09/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70104.4054
• Device Catalogue Number: 70104.4054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• 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