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

Model Number 701048012

Device Problems No Flow (2991); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/02/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Emdr report for the disposable (hls set) for this incident #(b)(4)/ mfg report number.8010762-2019-001650.

Event Description

It was reported that thy put the pt on and heparinized and the device quit working.No clots were observed and the act was 266.He switched out the hardware device and the disposable hls set after that it worked¿ fine¿.Complaint number (b)(4).

Manufacturer Narrative

It was reported, that the cardiohelp device quit working during treatment.The device was checked by a technician in the national service depot in mahwah.The technician run the device for several days.But he could not find any failure at the device.The disposable was also investigated in an other complaint.The outcome of that investigation for "no flow" was that the failure could not be reproduced.As during the investigation no failure could be found, no root cause could be determined.During the reported incident the machine quit working/ no flow the device was used for treatment.Thus the failure could not be confirmed.The occurence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action 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.A follow-up medwatch will be submitted when additional information becomes available.

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: 8738828
• MDR Text Key: 149792648
• Report Number: 8010762-2019-00196
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/26/2019

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: 701048012
• Device Catalogue Number: 701048012
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/03/2019
• Initial Date FDA Received: 06/27/2019
• Supplement Dates Manufacturer Received: 10/23/2019
• Supplement Dates FDA Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention