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

Model Number HEATER-COOLER UNIT

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).Field service technician (fst) was onsite.It was not possible to reproduce the reported issue.No device-error could be detected.According to the fst the most probable root cause was that the second patient water-connection was short-circuited with a shand, thereby the flow was strongly reduced.Furthermore the fst performed functioning test and a test run.All tests passed.The getinge director of clinical risk management & documentation reviewed the reported issue.In these circumstances, sufficient heat flow could not be ensured.Therefore no product related malfunction can be assumed.Thus the failure could not be confirmed.The issue was caused by an user error.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.

Event Description

After active cooling of the patient to 32 degrees celsius, the reheating to 36 degrees celsius over several hours was not possible, so the extra-corporal circulation finally ended at 34 degrees celsius.Device was replaced.No clinical consequences for the patient.(b)(4).

• Brand Name: MAQUET HCH 40
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 8479889
• MDR Text Key: 141056706
• Report Number: 8010762-2019-00090
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEATER-COOLER UNIT
• Device Catalogue Number: 701044054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention