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 11/01/2023

Event Type  malfunction  

Event Description

It was reported that the venous pressure was reading abnormally.The negative pressure was reading approximately ¿-499¿.Initially the pressure was reading within normal range and that the pressures were zeroed prior to placing the patient on support.The system was checked for kinks, clots, to lack of flow.The customer noted no adverse clinical criteria that would lead them to a solution for the excessively negative value.The technician advised the customer to swap the hls cable.The customer proceeded with swapping the hls cable and re-zeroed all three pressures.No harm to any person has been reported.Complaint id # (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

It was reported that the venous pressure was reading abnormally.The negative pressure was reading approximately ¿-499¿.Initially the pressure was reading within normal range and that the pressures were zeroed prior to placing the patient on support.The system was checked for kinks, clots, to lack of flow.The customer noted no adverse clinical criteria that would lead them to a solution for the excessively negative value.The technician advised the customer to swap the hls cable.The customer proceeded with swapping the hls cable and re-zeroed all three pressures.The failure occurred during treatment.A getinge field service technician (fst) was contacted by the customer.The fst confirmed that the defective hls cable does not have any visible damage.According to the fst, the customer ordered a new hls cable as a replacement.The fst stated that the customer has not reported any further failures regarding pressure.(refer to communications grid).The log files of the reported cardiohelp device were requested but could not be provided.No exact root cause could be determined.However, a similar failure was investigated by getinge life cycle engineering (lce).The root cause for the missing connection is 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.The cardiohelp serial number could not be provided.The review of the non-conformities has been performed on 2023-12-08 for the period of all nc to 2023-11-01.It does not show any non-conformity regarding 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 ¿high negative venous pressure" 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: 18100225
• MDR Text Key: 327714347
• Report Number: 8010762-2023-00560
• 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: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP-I
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1