MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH OTHER HARD-/SOFTWARE SYSTEMS; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS

Model Number VAVD

Device Problem Decrease in Pressure (1490)

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

Event Date 04/12/2022

Event Type  malfunction  

Event Description

It was reported that the maximum vacuum valve triggered for the first time at -130 mmhg, after that it went down to -120 mmhg on subsequent times.But it should be at -100 mmhg +-10%.Ref.#(b)(4).

Manufacturer Narrative

It was reported that the maximum vacuum valve triggered for the first time at -130 mmhg, after that it went down to -120 mmhg on subsequent times.But it should be at -100 mmhg +-10%.A getinge field service technician will be sent on-site for investigation of the device.As soon as new information become available, a follow up medwatch will be submitted.

Event Description

Complaint id (b)(4).

Manufacturer Narrative

It was reported that the maximum vacuum valve triggered for the first time at -130 mmhg, after that it went down to -120 mmhg on subsequent times.But it should be at -100 mmhg +-10%.The event occurred during start up.A getinge field service technician (fst) was on site and investigated the affected vavd controller serial# (b)(4) the fst could confirm the reported failure.Due to outstanding maintenance (last maintenance performed 2017).The fst performed the preventive maintenance, replaced the defective vavd membrane with the vavd maintenance kit (material#701035201), completed the pressure relief calibration and tested the device successfully for full functionality.Thus the reported failure could be confirmed.The most probable root cause for the reported failure is outstanding maintenance.According to the vavd controller service letter issue 01 / 10-02-02 vavd controller - inspection interval and servicing, the vavd must be inspected every 12 months.This contains the replacement of the vavd maintenance kit (70103.5201), including the vavd membrane.The fst confirmed that the membrane has been replaced during the last maintenance on 2017.The review of the non-conformities has been performed on 2022-04-25 for the period of 2011-06-28 to 2022-04-12.It does not show any non-conformity in regard to the reported product and failure.Production related influences are unlikely to have contributed to the reported failure.The product in question was produced in 2011-06-28 in order to avoid of reoccurance of the reported failure, the customer will be informed by the getinge sales and service unit (ssu) to follow the vavd controller service letter issue 01 / 10-02-02 vavd controller - inspection interval and servicing, the vavd must be inspected every 12 months.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary´s trending program and additional investigations or corrections will be implemented in case of adverse trending.

• Brand Name: OTHER HARD-/SOFTWARE SYSTEMS
• Type of Device: MONITOR, BLOOD-GAS, ON-LINE, 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: 14203113
• MDR Text Key: 295499656
• Report Number: 8010762-2022-00126
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K141233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VAVD
• Device Catalogue Number: 701024459
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1