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

Model Number CARDIOHELP-I

Device Problems Infusion or Flow Problem (2964); No Pressure (2994)

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

Event Date 09/27/2023

Event Type  malfunction  

Manufacturer Narrative

A getinge service technician will investigate the affected cardiohelp.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

It was reported that there were no pressure reading displayed.No harm to any person has been reported.Complaint id # (b)(4).

Manufacturer Narrative

It was initially reported that the no pressure readings were displayed.According to the customer, only the pven was displayed.The hls cable was exchanged during use.The hls disposable set was discarded and could not be investigated.The failure occurred during treatment.A getinge field service technician (fst) was sent for investigation and repair on 2023 (b)(6).No parts of the cardio help were replaced.Fst tested the hls cable provided and could not reproduce the failure.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The log files of the reported cardiohelp device were reviewed and the failure could not be confirmed on the date of event as there was no data for the date of event, 2023-09-27.An exact root cause could not be determined.However, according to the customer the hls cable was twisted,.A similar failure was investigated by the getinge life cycle engineering (lce).The root cause was determined to be a broken wire within the cable, which originated from external force.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 must 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 review of the non-conformities has been performed on 2023 (b)(6) for the period of 2021 (b)(6) to 2023 (b)(6).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.The device was manufactured on 2021-05-12.Based on the results the reported failure "no pressure reading" could not 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.

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: 17832142
• MDR Text Key: 324435061
• Report Number: 8010762-2023-00480
• 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: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• 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: 701072780
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1