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

Model Number HCU 30

Device Problem No Display/Image (1183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service technician (fst) was on site for further investigation and could confirm the failure "screen went black during case".Investigation is on-going.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Complaint #(b)(4).The hcu 30 display turned black during patient treatment.

Event Description

Complaint #(b)(4).

Manufacturer Narrative

It was reported that the display went black during a patient treatment.The getinge field service technician (fst) was sent for investigation on 2021-08-19.The fst could not reproduce the failure.All display cables were disconnected and reconnected.The customer was informed on how to adjust constrast and brigtheness in the device.The unit continued to be under observation.The fst was back on site on 2021-08-21, the failure was reproducible.The display was intermittently blank.The fst replaced the hood - hcu 30 top cover without operating panel (material 70103.4616), checked performeance of the system for more than 3 hours by achieving set max and min temp, with intermittent system reboot.All tests passed, the device is back in clinical use.In communication with the field service technician (fst) the most probable root cause for the failure "display not functioning" is a defective hood, which was no longer communicating with the pc load software.According to the hcu 30 service manual ( hcu 30 | service manual | english | 07| 6 pc load | hcu |54), with the pc load software the following procedures are performed: - softwares updates.To update display, control, safety and, if applicable rcu softwares; - calibrations.To calibrate temperature sensors, ice sensor, etc.; - loading / setting default values; - log viewer.To monitor data in the unit; - error code viewer.To show and interpret error messages; - display panel emulator.Therefore, if the hood is not communicating with the pc load software, the hcu 30 display is directly affected as no updates and calibrations can be performed.The review of the non-conformities has been performed on 2021-08-30 for the period of 2013-08-07 to 2021-08-30.It does not show any non-conformity in regard to the reported product and failure.There is no indication on manufacturing issues occurred during this time, thus production related influences are unlikely to have contributed to the reported event.The product in question was produced in 2013-08-07.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿ s trending program.Additional investigations, or corrective actions, will be implemented in the event of adverse trending.The occurrence rate was calculated for the reported failure and it was determined that this is not a systemic issue.Therefore, no remedial action is required.

• Brand Name: HEATER COOLER UNIT
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 12466039
• MDR Text Key: 271220340
• Report Number: 8010762-2021-00496
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K031544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HCU 30
• Device Catalogue Number: 701034642
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose