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

Model Number CARDIOHELP-I

Device Problem Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2020

Event Type  malfunction  

Manufacturer Narrative

A follow-up emdr will be submitted when additional information becomes available.

Event Description

While in use, the unit displayed a venous pressure of -500 and then the user stated that they could not correct the issue.The cardiohelp unit was replaced and set aside for inspection.Technicians remarks: customer complained that during use, the venous pressure dropped to -500 mmhg.It was stated that it then went into malfunction and the unit was replaced with another and set aside for inspection.12/2 - i arrive on-site and completed a visual inspection of unit and accessories.I found no issues with the visual inspection.I then completed the performance and service tool testing and found no issues.The unit was approved for clinical use but since it is a rental, the customer would like to have it replaced.I am sending it back to the depot for further inspections.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

According to service order 43534786 (dated 2020-12-02) no malfunction was found.Unit was send to the deport for further inspection.Under service order 43555549 it was found that the venous pressure was not zeroed (reads -500) when connected to the simulator at "0".The zero calibration was performed and unit passed all tests.Work performed on 2020-12-18/19/22/23.Based on this the failure could be confirmed but no product related malfunction.With reference to the current risk analysis most possible causes could be determined as follows: wrong pressure information due to: defective / disturbed (electro magnetic interfernece) pressure sensor, defibrillator system, laser scalpel, radio frequency system, response time is too long, positive or negative pressure beyond specification (release of tubes), software error, too high / low atmospheric pressure.The occurrence rate was calculated for the reported failure 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-I
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10974840
• MDR Text Key: 220740068
• Report Number: 8010762-2020-00429
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/29/2020
• Initial Date FDA Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR