MAUDE Adverse Event Report: MAQUET CARDIOPULMOARY AG MAQUET HEATER COOLER UNIT HCU 30; CONTROLLER, TEMPERATURE, CPB

Model Number 70102.8718

Device Problems Insufficient Cooling (1130); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2013

Event Type  Injury  

Event Description

On (b)(6) 2013 at (b)(6), it was reported that the hcu 30 base unit 200-240 v serial number (b)(4) stopped cooling on the cardioplegia side and started to heat which melted the ice block.There was also a burning smell reported from the unit.The device was taken out of service and the customer was given a loaner unit.There was no patient impact.(b)(4).

Manufacturer Narrative

Maquet medical system, usa submits this report on behalf of the legal manufacturer of the device, maquet cardiopulmonary (b)(4).On (b)(4) 2013 per service report (b)(4), the unit was investigated by a maquet service technician at the repair center and the terminal connector on the rear panel 12a breaker was found to be loose and arcing.The 12a breaker and connector were replaced.The tank return valve was found to be corroded and was replaced.The unit was tested to factory specifications and passed all tests.(b)(4).

• Brand Name: MAQUET HEATER COOLER UNIT HCU 30
• Type of Device: CONTROLLER, TEMPERATURE, CPB
• Manufacturer (Section D): MAQUET CARDIOPULMOARY AG; kehler strasse 31; rastatt, 76437 ; GM 76437
• Manufacturer (Section G): MAQUET CARDIOPULMOARY AG; kehler strasse 31; rastatt, 76437 ; GM 76437
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4280366
• MDR Text Key: 5297056
• Report Number: 8010762-2014-00871
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/15/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70102.8718
• Device Catalogue Number: 70102.8718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/15/2013
• Event Location: Hospital
• Date Report to Manufacturer: 07/15/2013
• Date Manufacturer Received: 07/15/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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