MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HEATER COOLER UNIT HCU40; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 70104.4054

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/15/2013

Event Type  Injury  

Event Description

On (b)(6) 2013 at the (b)(6) in (b)(6), it was reported that the hcu 40 serial number (b)(4) was exhibiting air in both the patient and cardioplegia circuit lines even after following the de-airing process.After 40 minutes of circulation the alarm sounded for air in the line and the device was removed from service.(b)(4).

Manufacturer Narrative

Maquet medical system, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).The device was evaluated by the r&d department in (b)(4) and it was determined that the device had a defective cplg bypass valve that was broken and leaked and the main bypass valve was blocked in an open position by dirt and corrosion caused by the water.(b)(4).

• Brand Name: MAQUET HEATER COOLER UNIT HCU40
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt, 76437 ; GM 76437
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt, 76437 ; GM 76437
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4944794
• MDR Text Key: 6037770
• Report Number: 8010762-2015-00622
• 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,User Facility,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/15/2013

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: 70104.4054
• Device Catalogue Number: 70104.4054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/15/2013
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2013
• Initial Date Manufacturer Received: 08/15/2013
• Initial Date FDA Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• 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