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

Model Number CARDIOHELP

Device Problem Device Fell (4014)

Patient Problem Death (1802)

Event Date 05/11/2020

Event Type  Death  

Manufacturer Narrative

A follow up will submitted when additional information becomes available.

Event Description

The following was reported: "when returning from the operating room, a wheel of the cart carrying the cardiohelp got stuck in a manhole cover, causing the device to fall.This alarmed and stopped functioning, stuck in safety mode, causing cardiopulmonary arrest for the patient.Current state of the patient: cardiopulmonary arrest (no flow 2 min, low flow about 1 hour).Death on (b)(6) 2020 from multiple organ failure with extensive irreversible digestive ischemia".The provided picture shows a non clinical transport vehicle.(b)(4).

Manufacturer Narrative

It was reported that, when returning from the operating room, a wheel of the cart, carrying the cardiohelp, got stuck in a manhole cover, causing the device to fall.This alarmed and stopped functioning, stuck in safety mode, causing cardiopulmonary arrest for the patient.The patient expired.The customer provided us with a picture of the trolley used to transport the cardiohelp.The picture shows that they did not use any product that is approved by maquet cardiopulmonary gmbh for the transport of the cardiohelp.Maquet cardiopulmonary requested the product in question for further investigation.The device is not available for technical investigation.Also the hls set is not available for technical investigation.The summary of the getinge medical review is as follows: the conclusion of the clinicians in the complaint was that the patient expired due to multiple organ failure and extensive, irreversible, digestive ischemia from serious voluntary drug intoxication which included cardiotoxics.While the patient was reported to be exposed to low (or no) flow after the cardiohelp fell to the pavement, the customer reinstituted support using the emergency drive until a replacement cardiohelp console was received.The use of the emergency drive in this condition seemed to be completely appropriate.The expiration of the patient appeared to be related to a chronic situation, but unrelated to the fall of the cardiohelp device to the pavement because support was reinstituted using the emergency drive after the fall of the device.As mentioned in the context of the complaint, no transport precautions (transport clamp, sprinter cart, transport holder, etc.) were implemented or taken by the customer.With reference to the current instruction for use (ifu) of the cardiohelp the following warning is stated: "when changing the mode of transportation, repositioning the patient or moving the patient outside the mode of transportation, there is a risk of decannulation and mechanical damage caused by strain on the tubes or impacts.The greatest care should therefore be exercised when carrying out these measures: take care in confined spaces, such as doorways and elevators.Do not allow tubes or cables to hang down.Ensure that there is no strain on tubes or cables.Avoid mechanical impacts and knocks.Avoid kinking tubes or cables.Do not drop any of the components.The ifu (instruction for use, cardiohelp system, 2 safety, chapter 2.2.26) includes the following warning: "for all other intra- and inter-hospital transportation, use the transport guard for cardiohelp disposables listed as an accessory to secure the disposable during transportation.Ensure that the fastener of the transport securing device is closed." furthermore, it is stated in chapter 4.2.3 that: "the transport holder hkh 8860 is mounted on the left-hand side on delivery: the position of operation of the cardiohelp-i is on the left side of the transport holder.If the position of operation is required on the right side, the transport holder must be converted." in chapter 4.2.2 (4.Secure the disposable with the transport guard for cardiohelp disposables) it is described to: "place the transport guard for cardiohelp around the disposable." before transportation, the following has to be checked (see instruction for use, cardiohelp system, check before every use in transportation, chapter 5.6.2): check the components for transportation.Check that all components for transportation (mobile holder hkh 8860, floor or wall holder, transport case for emergency drive and power supply cable) are present.Check that the components for transportation are functioning correctly.Check that the components for transportation have been correctly installed and secured.In the current risk analyses chapter 4.1.1.1.Most possible root causes could be determined as follows: fail of device by mechanical force e.G.Caused by loose connections caused by fall of device.Unsafe position / mounting / movement of device.Wear / loosening of components.Based on the above mentioned investigation results the reported failure could be confirmed, but not a product related malfunction.Thus no product related malfunction lead to the patient's death.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.

Event Description

Complaint number: (b)(4).

• Brand Name: CARDIOHELP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10749643
• MDR Text Key: 213498941
• Report Number: 8010762-2020-00358
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP
• Device Catalogue Number: 70104.8012
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death