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

Model Number CARDIOHELP-I

Device Problem Insufficient Cooling (1130)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2020

Event Type  malfunction  

Manufacturer Narrative

According to service report id#(b)(4) the affected device was sent to the repair depot (not in use anymore).The repair is ongoing.

Event Description

Complaint id# (b)(4).It was reported that one fan was defective.It was noted during patient treatment.No indication of actual or potential for harm or death.The device was replaced during treatment.

Manufacturer Narrative

The cardiohelp device was sent to the getinge national repair center in mahwah.A service technician (fst) was authorized for inspection and repair.The work was performed on 2021-01-06 and 2020-01-07.According to service report 43568363 the fst could confirm that the device had a "housing fan #1 error", caused by a wrong connection of the fan and the ecg-cable.After putting the cables in the correct connectors the device worked as per factory specifications.Based on this the reported failure could be confirmed.The most probable root cause is a maintenance failure as the cables were wrong connected.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 id# (b)(4).

• Brand Name: HEART LUNG MACHINE
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11013369
• MDR Text Key: 222845537
• Report Number: 8010762-2020-00438
• 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: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP-I
• Device Catalogue Number: 70107.2780
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 01/07/2021
• Supplement Dates FDA Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other