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

Model Number HL 20

Device Problem Pumping Stopped (1503)

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

Event Date 09/08/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported that the hl20 roller pump module was contaminated with blood.During operation on the patient, a luer lock had come off the pressure transducer (terumo set).A jet of blood from the arterial line then penetrated exactly into the rear ventilation slots of the arterial pump.This caused the tacho strobe for the speed control to become dirty and the error message "head" was displayed.The pump was replaced, the leak was eliminated and the perfusion was finished without any problems.A getinge field service technician (fst) was onsite for an investigation and repair on 2023-09-08.The fst turned on the pump which displayed the error message "head" immediately.The fst inspected the device in found contamination inside the pump due to the ingress of blood.The roller pump module was disassembled and cleaned, blood residue was removed, contacts and components cleaned.Drive belt replaced, calibrated and shielding and rubber feet renewed for hygienic reasons.After that the fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.According to the getinge field service technician the reported error message: "head" was caused due to contamination with blood which was spilled on the hl20 roller pump module.Based on the investigation results the reported failure "error message: "head"" could be confirmed.The device in question was manufactured on 2018-10-22.The review of the non-conformities during the period of 2018-10-22 to 2023-09-08 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.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.

Event Description

It was reported that the hl20 roller pump module was contaminated with blood.During operation on the patient, a luer lock had come off the pressure transducer (terumo set).A jet of blood from the arterial line then penetrated exactly into the rear ventilation slots of the arterial pump.This caused the tacho strobe for the speed control to become dirty and the error message "head" was displayed.The pump was replaced, the leak was eliminated and the perfusion was finished without any problems.Complaint id (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: 17822769
• MDR Text Key: 324330572
• Report Number: 8010762-2023-00477
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL 20
• Device Catalogue Number: 701028580
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2018
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1