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 12/01/2022

Event Type  malfunction  

Manufacturer Narrative

A follow up will submitted when additional information become available.

Event Description

It was reported: ¿both pressure and saturation sensors fail.¿no harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

A getinge field service technician (fst) was sent for investigation and repair.The venous probe cable and the connection cable for disposables were replaced.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

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the pressure and saturation sensor failed.On 2023-01-09 it was confirmed that the old venous probe cable was frayed and the connection cable of disposables has corroded pins.No patient was involved.The frayed venous probe cable is not reportable, as the venous probe is operated with a supply voltage of 9v.Voltages below 10 v can be perceived under certain conditions (e.G.Wet skin), but there is no risk for harm due to an electrical shock.Furthermore, the venous probe does not influence the blood flow of the device.The venous probe is for monitoring the blood gas values (hemoglobin (hb), hematocrit (hct), oxygen saturation (svo2) and venous temperature).The pressure failure is a reportable event, since every wrong pressure reading can lead to a pump stop, if the intervention is set by the user.A getinge field service technician (fst) was sent for investigation and repair.The venous probe cable and the connection cable for disposables were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.Another disposable connection cable with the same failure was investigated by getinge life cycle engineering on 2021-03-31.Deposit and oxides were found on the cable socket.By wetting the socket plane with salt-containing liquids (priming), the measurement signals were influenced by the electrical conductivity of the contamination.In may 2021 a service bulletin was published to make the users aware that the contacts of the plug connections must not come into contact with cleaning agents, disinfectants or priming liquid.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.Moreover, the root causes for the reported failure of the venous probe cable were identified under a corrective action preventive action (capa): - the venous probe cable is too short - the diameter of the cable is too high, which decreased the flexibility - the coating contains polyvinylchloride, which gets brittle when additives like plasticizers and stabilizers are vaporized.Sunlight and aggressive cleaners increase the aging.It was further determined in the capa that the old, short venous probe cable version was affected.As a corrective action a new venous probe cable (article #(b)(4)) was implemented, which is longer and has a smaller diameter.The coating contains polyurethane, which is weatherproof in all climatic zones and the risk for being brittle is low.According to service bulletin issue 91 / 21-02-18, the old cable is no longer available.The venous probe does not influence the blood flow of the device.The venous probe is for monitoring the blood gas values.In the instructions for use (ifu), chapter 2.2.5 "monitoring and sensors" of the cardiohelp system it is explained that these values must be regularly checked by the user via a blood gas analysis by a laboratory.Furthermore, in the ifu is stated that prior to a therapeutic measure based on the parameters displayed a laboratory blood gas analysis must be checked.The cardiohelp generates an acoustic and visible alarm in case of a failure of the venous probe.In addition in chapter 5.3 "connection the sensors" is explained how to ensure that the connected sensors are not defective and should not be use, if there is a visible damage.The venous probe is operated with a supply voltage of 9v.Voltages below 10 v can be perceived under certain conditions (e.G.Wet skin), but there is no risk for harm due to an electrical shock.Additionally the cardiohelp service manual enlists in chapter "1.11 maintenance overview" the demand for inspection tests, which has to be carried out every 12 months: 'visual inspection', 'electrical safety test', 'function test' and 'measured value and alarm monitoring'.The getinge service protocol contains the step: ¿venous probe visual test (holder, reference surface, probe, cable)¿.Any visual abnormality is inspected and must be confirmed if impeccable.Otherwise a replacement must be initiated.The device was manufactured on 2020-06-02.The review of the non-conformities has been performed on (b)(6) 2023 for the period of (b)(6) 2020 to (b)(6) 2022.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 investigation results the reported failures "defective venous probe cable and connection cable of disposables has corroded pins" 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 id: (b)(4).

• 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: 15915249
• MDR Text Key: 305905158
• Report Number: 8010762-2022-00485
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• 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
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1