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

Model Number CARDIOHELP-I

Device Problem Pumping Stopped (1503)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

A getinge field service technician (fst) had a call with the perfusionist.According to the protocol (written in service report id# (b)(4) , dated (b)(6) 2021) the customer denied access to the device as it is in use.After the patient treatment the fst will perform an investigation.

Event Description

Complaint number: (b)(4).It was reported that the pump stopped as there was a "bubble alarm".The customer had problems with resetting the alarm but finally the pump could be restarted.No negative impact of the patient was reported.

Manufacturer Narrative

It was reported that the pump stopped as the bubble alarm could not be aknowledged by the customer.This is needed to restore the blood flow.The getinge service technician stated that no service will be performed as the bubble intervention could not be set due to a training issue.Based on this the reported failure could not be confirmed.The root cause is an inadequate knowledge of the hospital staff, which will be trained by the field service technician.The intervention setting is explained in the instructions for use (ifu cardiohelp system), chapter 6.1.5 activating/deactivating interventions with button combinations.The device history record does not show any abnormality or issue that is related or can have led to the customer 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.

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: 11258431
• MDR Text Key: 233496984
• Report Number: 8010762-2021-00092
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP-I
• Device Catalogue Number: 70107.2780
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other