MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG TUBING, PUMP, CARDIOPULMONARY BYPASS

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem Cardiac Arrest (1762)

Event Date 09/12/2017

Event Type  Injury  

Manufacturer Narrative

This report is being submitted because importer- follow-up #1 was originally reported under mfg report # 8010762-2016-00599 on (b)(6) 2016.The trackwise system did not issue a uf/importer report # on that report because the initial medwatch report was only for the manufacturer and was not importer reportable.This report is now being issued so a importer report # will be generated.

Event Description

Additional information received (b)(6) 2016 the hospital submitted a facility medwatch report uf/importer/report # (b)(4): patient was on ecmo machine for several days.The ecmo (cardiohelp) circuit screen went black, patient was bagged and pressors started.Epinephrine given while the ecmo specialist started to hand crank the ecmo circuit.Attempts to turn on the cardiohelp failed.Machine / circuit switched out.The patient coded during this time and survived.(b)(4).

Manufacturer Narrative

(b)(4).No investigation by field service technician, as the customer services their own devices.No service order and no further information is available for this case.The device is back in use and the customer replaced no parts.The data is also being handled through a designated trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

Event Description

(b)(4).

• Brand Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 6825418
• MDR Text Key: 83831453
• Report Number: 3008355164-2017-00019
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2016,08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/20/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/23/2016
• Date Manufacturer Received: 10/23/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention