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

Model Number CARDIOHELP-I

Device Problem Communication or Transmission Problem (2896)

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

Event Date 07/21/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported that the old style venous probe cable was frayed and there were faulty pressure readings.Both failure occurred during treatment.The cardiohelp was exchanged.A getinge field service technician (fst) was sent for investigation and repair on 2023-08-17 and 2023-08-20.The venous probe cable was replaced.According to the fst, the faulty pressure readings could not be replicated, hence no parts were replaced for this failure.Furthermore, according to the fst, there was no damage on the hls cable.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The affected hls set is not available for investigation, as it was discarded by the customer.For the failure "venous probe cable frayed", the root causes were identified under capa#383305 as the following: - 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.In february 2021 a service bulletin (issue 91 / 21-02-18) was published to make the users aware that the old cable is no longer available, because it was replaced by a new venous probe cable (article #70107.2695), which is longer and has a smaller diameter.The coating was also improved and now contains polyurethane, which is weatherproof in all climatic zones and the risk for being brittle is low.This design changes were implemented as part of capa 383305.Based on this the reported failure "venous probe cable damaged" could be confirmed.According to the risk file of the cardiohelp device the following root causes can lead to the reported pressure reading failure: - wrong plugged external pressure sensor or disconnection (mix up) - disturbed (emi) pressure sensor - defibrillator system - connection of non-compatible sensor - response time is too long - too high / low atmospheric pressure 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'.Any visual abnormality is inspected and must be confirmed if impeccable.Otherwise a replacement must be initiated.Moreover, according to the instruction for use of the involved disposables (hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0, v2.4, chapter 6.1 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.Furthermore, 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 (ifu) of the 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.The device in question was manufactured on 2017-02-15.The root cause for the failure "frayed venous probe cable" was determined as a systemic issue and capa#383305 was initiated to take actions.In february 2021 a service bulletin (issue 91 / 21-02-18) was published to make the users aware that the old cable is no longer available, because it was replaced by a new venous probe cable (article #70107.2695).The review of the non-conformities for the failure "faulty pressure readings" has been performed on 2023-08-23 for the period of 2017-02-15 to 2023-07-21.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.Based on the results the reported failure "venous probe cable frayed" could be confirmed and the failure "faulty pressure readings" could not 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

It was reported that the old style venous probe cable was frayed and there were faulty pressure readings.Both failure occurred during treatment.The cardiohelp was exchanged.No harm to any person has been reported.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: 17610938
• MDR Text Key: 321819062
• Report Number: 8010762-2023-00415
• 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
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• 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: 08/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1