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

Model Number 701044054 - HCU 40

Device Problem Insufficient Cooling (1130)

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

Event Date 09/10/2019

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Ice loss during the operation.Warm water runs back into the tank and makes the ice melt.(b)(4).

Manufacturer Narrative

According to the service report dated on 2019-09-10 the field service technician has replaced the following components: valve kit (material#: 70107.1778), vacuum valves (material#: 70106.4680) and shunt valve (material#: 70107.1568).This case has already been investigated in complaint: (b)(4): according to the investigation report lce04268 dated on 2019-09-06 the valves are defective.They do not close completely, it can happen that warm water flows into the tank and the desired amount of ice cannot be built.Due to the visuell investigation deposits on the o-rings was found.The deposits on the o-rings could most likely have led to the leakage of the valve.Thus the reported failure could be confirmed.The hcu 40 risk analysis version v17 (dms#: 2023635) was reviewed and the failure is assessed in section: risk id: h9.2.1.18 possible causes: too low amount of ice building: sensor failures, use of water out of spec.(conductivity).Software error, defective compressor or coolant circuit, software error.Since the incident is below the accepted rate, no remedial action is necessary.The ocurrance rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaint number: (b)(4).

• Brand Name: HEATER COOLER UNIT
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9138529
• MDR Text Key: 195103833
• Report Number: 8010762-2019-00309
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K130300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 701044054 - HCU 40
• Device Catalogue Number: 701044054
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1