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

Model Number 701072780 - CARDIOHELP-I, US-VERSION

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Injury (2348)

Event Date 08/05/2019

Event Type  Injury  

Event Description

It was reported from a customer from the us that cardiohelp used for v/a support during a lung transplant/cabg procedure.At or around 4 hours on the cardiohelp, echo/tee shows copious amount of air in the aortic root, ascending and descending aorta- nothing inter-cardiac noted.Dr.(b)(6) (performing surgeon) has concerns that the cardiohelp might have allowed air to pass through oxygenator then into the patient.The bubble detector was never trigger by air, no visible or audible air was noted throughout the run.Additional information: bubble alarm did not activate but was active per customer, outcome was multiple strokes and eventual death, echo = echocardiogram, no cracks noted in system, cannulas appeared functional and were checked per surgeon.The affected disposable will be handled under complaint id: (b)(4).Follow up information: new relevant information received on 2019-08-20.According to the perfusionist which was involved in the incident: ¿she states that this patient is not deceased, the patient is still alive but not waking up from multiple strokes.Please note the patient has not expired!¿ (b)(4).

Manufacturer Narrative

Device serial#(b)(6): according to the service order report 43096749 (dated 2019-08-19/20) the technician checked out the flow sensor 82599 from the cardiohelp#90411418 and stated: "customer has concerns that the cardiohelp might have allowed air to pass through oxygenator then into the patient.The bubbledetector was never triggered by air, no visible or audible air was noted throughout the run.Serial number of cardiohelp and flow/ bubble sensor was not noted at time of incident.It was determined that all cardiohelps flow/bubble sensors should be checked to ensure proper operation.Fbs alarms using test circuit.No problem could be found.Downloaded logs.Returned to customer for clinical use." device serial#(b)(6): according to the service order report 43096782(dated 2019-08-19) the technician checked out the flow sensor 82606 from the cardiohelp#(b)(6) and stated: "customer has concerns that the cardiohelp might have allowed air to pass through oxygenator then into the patient.The bubble detector was never triggered by air, no visible or audible air was noted throughout the run.Serial number of cardiohelp and flow/ bubble sensor was not noted at time of incident.It was determined that all cardiohelps flow/bubble sensors should be checked to ensure proper operation.Fbs alarms using test circuit.No problem could be found.Downloaded logs.Returned to customer for clinical use." device serial#(b)(6): according to the service order report 43100202(dated 2019-08-23/26) the technician checked out the the cardiohelp#(b)(6) and stated: "customer has concerns that the cardiohelp might have allowed air to pass through oxygenator then into the patient.The bubble detector was never triggered by air, no visible or audible air was noted throughout the run.Serial number of cardiohelp and flow/ bubble sensor was not noted at time of incident.It was determined that all cardiohelps flow/bubble sensors should be checked to ensure proper operation.Fbs alarms using test circuit.No problem could be found.Downloaded logs.Returned to customer for clinical use." according to a later communication with the ssu customer told that the cardiohelp with serial#(b)(6) was directly involved.Thus the failure could not be confirmed due to the fact that the technician could not confirm the failure in the affected device and in the two other devices in question.Therefore a most probable root cause could not be determined.Clinicial assessment was requested on 2019-08-19.2019-09-20: to perform a clinical evaluation is not possible due to lack of information.The requested necessary questionaire was not provided after serveral reuqests by the customer, therefore no clinicial evaluation is possible.The ocurrance rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿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-I, US-VERSION
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 8939158
• MDR Text Key: 155794863
• Report Number: 3008355164-2019-00013
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 701072780 - CARDIOHELP-I, US-VERSION
• Device Catalogue Number: 701072780
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 09/30/2019
• Distributor Facility Aware Date: 09/20/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening