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

Model Number CARDIOHELP-I

Device Problem Pumping Problem (3016)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted when new information become available.

Event Description

The patient was connected for 2 days, after that appears the message showed in the picture (disposable pump error - stop), then the patient had to be hand cranked with the emergency drive and the oxigenator membrane worked.The customer started the machine and the error showed again after 3 tries the machine worked normally again.After 3 hours of use the message appeared again.(b)(4).

Manufacturer Narrative

New information received on 2020-12-14: event occurred in argentina, not colombia.

Event Description

Complaint number: (b)(4).

Manufacturer Narrative

According to the information from 2020-12-01 the complaint was created in error.Thus no service was performed.Based on this the reported failure could not be confirmed.The most probable root causes of the ¿pump disposable error¿ found in similar cases are: - the disposable was disconnected from the cardiohelp during the pump is running.- the user did not set the pump to zero before connecting the disposable (refer to the instruction for use of hls set, chapter 5.3.1).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-I
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10784205
• MDR Text Key: 214561799
• Report Number: 8010762-2020-00374
• 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: consumer,distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2020

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: 70104.8012
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 12/01/2020; 12/14/2020
• Supplement Dates FDA Received: 12/10/2020; 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other