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

Model Number 701048012 - CARDIOHELP-I

Device Problems No Flow (2991); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2019

Event Type  malfunction  

Manufacturer Narrative

The defective senor panel is already requested for further investigation.A follow up medwatch will be submitted when additional information becomes available.

Event Description

It was reported, that they were not able to generate any flow and that the device showed error messages.To solve the problem, they switched to the emergency drive (hand crank) and later transferred the circuit to another cardiohelp device, which solved the problem.No harm to patient reported.(b)(4).

Manufacturer Narrative

The initial failure description was that they had no flow and got the error message device defective.The device was by the technician removed from the hospital and the sensor panel sent for investigation to rastatt germany.The repair of the device was according to the received email done on 2020-03-16.The unit passed all tests after repair.According to the life cycle engineering investigation (lce) with the number lce4280 from 2020-03-06 the investigated sensor panel had no defect, but the lce could reproduce the event according to the description and the provided log-files.Further according to the investigation the cardiohelp (ch) with the serial number (b)(6) behaved as intended at the time of the claimed incident.The most likely root cause of the complained behavior is assumed to be a blockage of the blood circulation.What caused the blockage of the blood flow could not be determined in the context of this investigation.The problem with the error messages they experienced was not caused by the investigated sensor panel.This blockage of the blood flow triggered various overload mechanisms at the ch, which in turn have activated the '0002e02 backflow prevention'.The occurrence rate is below the acceptance rate, thus no remedial action 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

Complaintnumber: (b)(4).

• 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: 8943815
• MDR Text Key: 162130397
• Report Number: 8010762-2019-00271
• 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: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701048012 - CARDIOHELP-I
• Device Catalogue Number: 701048012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Initial Date Manufacturer Received: 08/08/2019
• Initial Date FDA Received: 08/29/2019
• Supplement Dates Manufacturer Received: 03/06/2020
• Supplement Dates FDA Received: 03/21/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention