MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number CARDIOHELP

Device Problem Communication or Transmission Problem (2896)

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

Event Date 04/26/2022

Event Type  malfunction  

Event Description

A defective arteriel bubble sensor (flow/bubble sensor) was reported.No harm to any person has been reported.New information received on 2022-05-05, that the cardiohelp was exchanged during treatment.Complaintnumber: (b)(4).

Manufacturer Narrative

A follow up will be submitted when additional information become available.A getinge technician will investigate the cardiohelp in question.

Manufacturer Narrative

A defective arterial bubble sensor (flow/bubble sensor) was reported.Customer reported, that the bubble sensor was not reading any values.The time of occurence was not provided.A getinge service technician (fst) was sent for investigation and repair on 2022-04-26/27.The flow/bubble sensor was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.It was confirmed by fst, that most probably customer used non getinge parts.The review of the non-conformities has been performed on 2022-05-16 for the period of 2012-10-01 to 2022-04-26.It does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely to have contributed to the reported failure.Based on the results the reported failure "defective arterial bubble sensor (flow/bubble sensor)" could be confirmed.The customer will be informed about the results by the getinge sales and service unit.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.

Event Description

Complaint number: (b)(4).

• Brand Name: HEART LUNG MACHINE
• Type of Device: CONSOLE, HEART-LUNG MACHINE, 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: 14335137
• MDR Text Key: 291244178
• Report Number: 8010762-2022-00157
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP
• Device Catalogue Number: 701048012
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1