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 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).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The initial failure description was that the rotaflow drive "closing assay 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 2021-02-26.On 2021-03-16 emtec could confirm the reported failure.The root cause analysis for the reported failure "closing assay broken" showed following details: the closing assay does not indicate any signs of material fatigue.As reported by the customer an external force caused the breakage of the closing assay.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 assay, was the cause of the breakage.

• 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: 11013925
• MDR Text Key: 221711509
• Report Number: 3008355164-2020-00026
• Device Sequence Number: 1
• Product Code: KFM
• 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: 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2021
• Distributor Facility Aware Date: 03/17/2021
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2021
• 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