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

Model Number CARDIOHELP-I

Device Problem Infusion or Flow Problem (2964)

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

Event Date 01/04/2024

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 the there was a flow issue.The failure occurred during transportation.According to the technician, ¿disposable was successfully primed with no issues but would not produce forward flow when connected to the patient.Venous line was disconnected, and cannula checked for drainage with no issue.Backflow prevention was ruled out.The cardiohelp was placed in global override and still would not produce flow.The disposable was removed from the cardiohelp drive system and connected to the handcrank with the flow bubble sensor still attached.The customer was able to generate forward flow with the handcrank based on the reading from the flow probe.The patient was transported to the receiving hospital on the handcrank and converted to another device¿.Additionally, according to the technician, the customer clamped the lines and turn the rmp to 0 to rule out pump disposable error.No harm to any person has been reported.Complaint id # (b)(4).

Event Description

Complaint id # (b)(4).

Manufacturer Narrative

It was reported that the there was a flow issue.According to the technician, ¿disposable was successfully primed with no issues but would not produce forward flow when connected to the patient.Venous line was disconnected, and cannula checked for drainage with no issue.Backflow prevention was ruled out.The cardiohelp was placed in global override and still would not produce flow.The disposable was removed from the cardiohelp drive system and connected to the emergency drive (e-drive) with the flow bubble sensor still attached.The customer was able to generate forward flow with the e-drive, based on the reading from the flow probe.The patient was transported to the receiving hospital on the e-drive and converted to another device¿.Additionally, according to the technician, the customer clamped the lines and turn the rmp to 0 to rule out pump disposable error.The failure occurred during transport.The hls set will be investigated in complaint # (b)(4).The getinge field service technician (fst) performed repair and diagnosis on 2024-01-22/23.No parts were replaced.The repair depot tested the cardiohelp for nine consecutive days at 3200 rpm at 4 lpm with no failures.The log files were analyzed and according to the analysis, the error messages indicate a faulty disposable.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 "pump stop", "backflow prevention", "rpm control error", "device defective (0xd00e)", "pump disposable error", "no disposable detected" could be confirmed on the date of event, 2024-01-04.The root cause could not be determined as the repair depot could not replicate the failure.According to the technician, a probable root cause is a faulty disposable.The cardiohelp includes pressure sensors and a venous probe it can 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.In the cardiohelp instructions for use (ifu) chapter 6.4.4 "using the emergency drive with the disposable hls retainer" is stated that the emergency drive can be used to manually control the blood flow in case of a failed cardiohelp.The review of the non-conformities has been performed on 2024-01-18 for the period of 2018-04-16 to 2024-01-05.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 2018-04-16.Based on the results the reported failure "no flow" 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: 18510372
• MDR Text Key: 333025257
• Report Number: 8010762-2024-00025
• 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: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• 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: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1