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

Model Number CARDIOHELP-I

Device Problems Communication or Transmission Problem (2896); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/14/2021

Event Type  malfunction  

Manufacturer Narrative

Service of the affected cardiohelp and return of the involved hls set is pending.A follow-up emdr will be submitted when additional information becomes available.

Event Description

The customer reported that the cardiohelp gave error message device defective(0xd00e) during treatment.In addition unusual sound of the pump was reported.The cardiohelp and hls circuit was exchanged.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the unit made an unusual sound during use after a "device defective" error message was displayed.The cardiohelp and hls set were replaced during treatment.A getinge service technician investigated the unit on (b)(6) 2021 and could not duplicate the failure.The technician performed safety, calibration, and functionality checks to factory specifications.For further investigation the involved hls set was technically investigated in the getinge laboratory on (b)(6) 2021.Heavy clotting in the oxygenator and especially in the centrifugal pump was noted.The clots could not be removed complete.During function testing of the pump an imbalance and unusual noise could be observed caused by the clots.The log files of the cardiohelp unit were analysed by getinge life cycle engineering for the reported event time.The error message "device defective" could be confirmed.This error is as result of differences between the set and real flow.This could be caused by the clots confirmed in the laboratory investigation of the hls set.Based on the investigation results the reported failures "device defective error message" and "unusual sound" could be confirmed but no product related malfunction.The most probable root cause was determined as heavy clotting disturbing the centrifugal pump.With reference to the risk assessment of the associated hls set (hls set advanced 5.0 / hls set advanced 7.0, dms # 1468452, v26) and in consultation with the getinge manager medical affairs team the following events can contribute to clotting in the circuit: -air remains in or enters the circuit - inappropriately low, or no blood flow, in the circuit -improper hemostasis -too low anticoagulation -too low act level, effect of heparin is too limited -protamine sulfate enters the hls set -administration of congealable substances (such as platelets) or pro-coagulant medications.-(consumption) coagulopathy the occurrence rate was calculated for the reported failure 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: CARDIOHELP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 11889662
• MDR Text Key: 256204915
• Report Number: 8010762-2021-00314
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• 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: 06/28/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1