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

Model Number ROTAFLOW

Device Problem Battery Problem (2885)

Patient Problem Death (1802)

Event Date 08/28/2020

Event Type  Death  

Manufacturer Narrative

A follow up will be submitted if additional information becomes available.

Event Description

The following was reported: "shut off mid transport yesterday and i have placed a "broken" tag on it" additional information received that it was due to battery charging failure.(on (b)(6) 2020 factory submitted a malfunction emdr based on this information).(b)(6) 2020 received information that the patient died.(importer emdr being submitted) (b)(4).

Manufacturer Narrative

Patient expired but not as a result of this.Patient had a brain bleed.Factory received information about death on sept 11,2020.

Event Description

(b)(4).Importer became aware that patient had a brain bleed on sept 30 2020.

Event Description

Complaint number: (b)(4).

Manufacturer Narrative

A shut off of the rotaflow during patient transport was reported.On 2020-09-11 getinge received the information that the patient expired as a result of brain bleed and the customer confirmed the death of this patient was not product related.The device history record (dhr) of the rotaflow (material: 70104.3292, serial: 94175406) for which a customer complaint was received, was reviewed on 2020-09-02.The dhr does not show any abnormality or issue that is related or can have led to the customer complaint.A getinge field service technician (fst) was on site on 2020-08-28 and could not reproduce the reported failure.He replaced the battery of the rotaflow unit on 2020-11-05 in order to send the batteries to the factory for investigation.The unit was tested as per factory specifications and passed all tests.The unit was put back in use.The battery was investigated by life-cycle-engeneering on 2021-01-18 with the following outcome: 6 of 20 battery cells were found defective, which was affecting the power loss of the rotaflow.According to the service order report #43438199 the rotaflow was operated for at least one hour after the complaint event.Therefore the discovered defects must happened after the event date.Getinge is not aware of how long the rotaflow was operated with on battery during the event or if it was fully charged before.Based on these information, it is not possible to determine an exact root cause however the most probable root cause could be determined as a not fully charged battery or a battery runtime of over 1,5 hours.A medical review was performed by getinge medical experts on 2021-02-25: after the assessment of all available data no causality between the patient¿s death and the device functionality could be found.Mitigations are included in the instruction for use (ifu rotaflow| 4.2 | en | 13 ) as warnings in chapter 3.3.4 battery operation: check battery capacity every 6 months, at the latest.The battery must be replaced by the authorized technical service every 2 years, at the latest.The battery must be replaced sooner if it cannot be fully charged within 8.5 hours or if the system cannot be operated with the fully charged battery.The actual run time during battery operation depends on the age and condition of the batteries, current consumption of the rotaflow console and other factors.The run time shown is only a reference value.The actual run time can be shorter or longer.The rotaflow risk analysis version v06 (dms# 2023689) chapter h1.1.1.21 was reviewed and can be linked to the reported failure as follows: the most possible causes for the reported failure "shut off of the device due to battery" are: defect batteries, software error, user forgot recharge, defect of charger unit.Based on the above mentioned investigation results the reported failure "shut off of the device" could be confirmed, but there is no relation to a product malfunction.Thus no product related malfunction lead to the patient's death and the patient expired due to causes unrelated to the nature of the complaint.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.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.

• 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: 10601810
• MDR Text Key: 209112915
• Report Number: 3008355164-2020-00017
• 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,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW
• Device Catalogue Number: 701043292
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2021
• Distributor Facility Aware Date: 02/25/2021
• Device Age: 21 MO
• Event Location: Home
• Date Report to Manufacturer: 03/08/2021
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 69 YR
• Patient Weight: 61