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

Model Number CARDIOHELP-I

Device Problems Communication or Transmission Problem (2896); Pressure Problem (3012)

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

Event Date 03/10/2023

Event Type  malfunction  

Manufacturer Narrative

A getinge field service technician (fst) was sent for investigation and repair on (b)(6) 2023.The pressure failure could not be replicated.The connection cable for disposables was replaced as a precautionary measure.The reported error message "ven.Bubbles sensor defective" could be reproduced by fst one time by moving the connection on the back of the cardiohelp.He cleaned and reseated the connection several times and could not longer reproduce the error, but he found a bit of dried blood residue around the base of the connection.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.A follow up will submitted when additional information become available.

Event Description

The customer reported that during past 2 days they got weird alarms (pressures/delta p gives wacky numbers/error message ¿venous bubble sensor defective¿).No harm to any person has been reported.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that during two days of the treatment there were alarms on the cardiohelp device (pressures/delta p gives wacky numbers/error message ¿venous bubble sensor defective¿).A getinge field service technician (fst) was sent for investigation and repair on 2023-03-16.The pressure failure could not be replicated.The connection cable for disposables was replaced as a precautionary measure.The reported error message "ven.Bubbles sensor defective" could be reproduced by the fst one time by moving the connection on the back of the cardiohelp.He cleaned and reseated the connection several times and could not longer reproduce the error.He found a bit of dried blood residue around the base of the connection.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The provided log files does not include the reported date of event: 2023-03-10.Moreover, the logs file analysis of the fst indicates that the unit was in use on 2023-03-05 and 2023-03-07.On this date the pressure values were inconsistent over the time frame of a couple days.The related hls set is not available for investigation.An exact root cause for the failure "pressures/delta p gives wacky numbers" could not be identified.However, according to the risk file v24 of the cardiohelp device the following root causes can lead to the reported failure: wrong pressure information e.G.: wrong plugged external pressure sensor or disconnection (mix up), disturbed (emi) pressure sensor, response time is too long, too high / low atmospheric pressure.According to the instruction for use of the involved disposables (hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0, v2.3, chapter 7.1 preparation and installation and quadrox-ir small adult / adult, chapter 7.2 priming the system) the pressure sensors have to be calibrated and checked before priming.Further the cardiohelp has a flow/bubble sensor and a venous probe to measure and control the blood flow and parameters.If the measured values are above high limit or below low limit of the set limits the system generates a visual and acoustical alarm.According to the instruction for use (cardiohelp, chapter 5.3 "connection the sensors") it is stated to ensure that the connected sensors are not defective and to not use, if there is a visible damage.As confirmed by the fst, the root cause for the reported error message "ven.Bubble sensor defective" could be identified as dried blood residue on the connection.According to the instructions for use (ifu), chapters 2.2.5 "monitoring and sensors" and 5.4.4 "bubble monitoring: function test" the venous bubble sensor and the arterial flow/bubble sensor have to be tested before each use.The cardiohelp has a flow/bubble sensor for bubble detection.The venous bubble sensor is optional and for additional bubble detection.According to the instructions for use (ifu) of the caridohelp (chapter 10 cleaning and disinfection) the cables and the whole device should be cleaned after each use to remove soiling or residual blood.Furthermore in chapter 5.3 connecting the sensors it is stated that the sensors must be kept clean.The device was manufactured on 2017-04-26.The review of the non-conformities has been performed on 2023-03-16 for the period of 2017-04-26 to 2023-03-10.It does not show any non-conformity in regard to the reported product and failures.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.Based on the results the reported failure "pressures/delta p gives wacky numbers" could not be confirmed and the failure "venous bubble sensor defective" could be confirmed.The customer will be informed about the results by the getinge sales and service unit.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: CARDIOHELP
• 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: 16654122
• MDR Text Key: 312505616
• Report Number: 8010762-2023-00155
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

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: CARDIOHELP-I
• Device Catalogue Number: 701048012
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2023
• Initial Date FDA Received: 03/31/2023
• Supplement Dates Manufacturer Received: 04/04/2023
• Supplement Dates FDA Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1