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

Model Number CARDIOHELP-I

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 04/02/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

Customer reported about noise coming from the cardiohelp.Circuit was on a patient for four days, it started making an odd humming sound from the hls.Patient expired while he was still on the circuit.An additional complaint for the hls set 165185 was opened in order to track and trend the detected failure.(b)(4).

Event Description

Ref.: # (b)(4).Customer ref: (b)(4).

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).Importer- maquet medical systems usa, 45 barbour pond drive, wayne, nj 07470.Contact person- (b)(6).The device has been sent to mahwah repair depot.Repair performed on 2018-05-29 and 2018-05-31.Results of summary report 42544326: unit was updated with the latest sw 03.04.08; cardio help sn# 90410747 has been running with a test circuit for over a month.Unit has been running 24 hours a day at 4,000 rpm¿s holding 3.0 lpm.The unit has not made one noise.I was not able to verify the customer's complaint.The sensor panel was sent to life cycle engineering (lce) in rastatt, germany.Investigation performed on 2019-03-11.Investigation report received on 2019-04-15.Results of investigation report lce 03935: all tests performed in the sensor panel (running test with hls module, temperature increment in the pump drive) did not show any abnormality and did not lead to reproduce the described error and therefore to determine its origin.Due to the fact that there are no moving or loose parts inside the pump drive of the sensor panel, the reported noise could have been generated only by the disposable.A test running the hls module without liquid inside generated a scratching noise coming from the disposable.The associated hls set was not provided for this investigation and therefore not further inspection can be can be done in this direction.No root cause could be found.Thus the failure could be confirmed.Since the sensor panel had no malfunction, no corrective action is needed.In addition at this time it cannot be concluded that it is a systemic error.No corrective action is needed.Note: complaint for disposable: (b)(4).

• Brand Name: HEART-LUNG BYPASS SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7472821
• MDR Text Key: 106901929
• Report Number: 8010762-2018-00158
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/11/2018,05/07/2019

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: 701048012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/30/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2018
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 04/30/2018
• Supplement Dates Manufacturer Received: 04/14/2019
• Supplement Dates FDA Received: 05/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death