MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number ROTAFLOW DRIVE

Device Problem Break (1069)

Patient Problems Death (1802); Hypovolemia (2243)

Event Date 12/08/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that an undefined object had fallen on the rotaflow drive.The rotaflow closing assy as well as the disposable broke.The patient expired.Complaint id: (b)(4).

Manufacturer Narrative

The initial failure description was that the rotaflow drive "closing assy is broken".The failure occurred during patient treatment and the patient expired.The affected drive with the serial number (b)(6) was send back to the supplier (emtec) for repair and further investigations on (b)(6) 2021.On (b)(6) 2021 emtec could confirm the reported failure.The root cause analysis for the reported failure "closing assy broken" showed following details: the closing assy does not indicate any signs of material fatigue.As reported by the customer an external force caused the breakage of the closing assy.The breaking edge of the closing indicates that an improper impact has led to the damage.The top of the rotaflow drive shows a significant scratch.From the suppliers point of view has the drive been hit by an object.Furthermore, the hydraulic pin of the mast holder is missing from the arm.It is unclear whether the pin was already missing at the time of the damage and therefore the arm could not be fixated.The missing hydraulic pin was not reported by the customer.The function test has been performed and the device is working as intended.The most probable root cause could be determined as damage by a third party.The trend review shows that this is an isolated event, where an object hitting the closing assy, was the cause of the breakage.A medical review was performed by manager medical affairs on (b)(6) 2021 with following outcome: - it first was reported that an object fell on the rotaflow drive -further correspondence showed the broken rotaflow closing assy as well as a broken disposable pump head -fracture occurred sometime during transfer/transport to scanning of the patient -the patient was a 36 year old male on both heartmate and veno-venous ecmo (extracorporeal membrane oxygenation) support.-the location of the fracture of the closing assembly suggests that the closing assembly hinge was exposed to inordinate stress/force in an upward, then lateral, direction -while the centrifugal head is not within purview of this review, the location of its fracture seems to suggest an upward stress/force that was applied to the centrifugal head, fracturing the outlet of the centrifugal head at a non-seamed location -despite the details provided in the context of the complaint, as well as from follow-up correspondences, no clear explanation can be advanced as to the source, reason, or contributing factors that lead to the fracture of the rfd closing assembly.-the expiration of the patient is likely due to an unfortunate confluence of issues including poor prognosis and, presumably, hemodynamic deterioration after the fracture of both the centrifugal head and the rfd closing assembly.While no clear root cause(s) contributing to the fracture of rfd closing assembly (or the centrifugal head) could be determined from the information provided, the photos seem to suggest possible mishandling of the rfd either during transport of the patient or in the course of the ct scan.In conclusion: it appears that excessive external force was likely applied to the rfd, breaking the closing assembly as well as the centrifugal head inside the drive.The product in question was produced in (b)(6) 2012.The review of the non-conformities during the period of (b)(6) 2012 to (b)(6) 2020 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 can be excluded.Based on these investigation results the reported failure could be confirmed, but no product related malfunction could be confirmed, as the closing assy was broken by external force.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.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.

Event Description

Complaint id: (b)(4).

• Brand Name: HEART LUNG MACHINE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11013269
• MDR Text Key: 221706527
• Report Number: 8010762-2020-00437
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K991864
• 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: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW DRIVE
• Device Catalogue Number: MCP0.0952291
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 36 YR
• Patient Weight: 136