MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLM TUBING SET W/BIOLINE COATING; TUBING, PUMP, CARDIOPULMONARY BYPASS

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Injury (2348)

Event Date 08/05/2019

Event Type  Injury  

Manufacturer Narrative

A follow up medwatch will be submitted when additonal information becomes available.

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.The disposable in question is no longer available for return.Which hls set was used in requested but still pending.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 cardiohelp 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!¿ complaint id: (b)(4).

Manufacturer Narrative

Maquet cardiopulmonary gmbh requested the product for investigation but the product was not available.Therefore no laboratory investigation could be performed by the manufacturer.A review for similar complaints to be investigated already was performed and no similar complaints were found.Thus the failure could not be confirmed.Based on the information available at this time the cause of this failure was not attributed to a device related malfunction.Clinical 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 several requests by the customer, therefore no clinical evaluation is possible.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: HLM TUBING SET W/BIOLINE COATING
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 8938683
• MDR Text Key: 160616543
• Report Number: 8010762-2019-00264
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K080592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 09/29/2019

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2019
• Initial Date FDA Received: 08/28/2019
• Supplement Dates Manufacturer Received: 09/20/2019
• Supplement Dates FDA Received: 09/30/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening