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

Model Number 701048012

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 04/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).(b)(6).

Event Description

(b)(4).During patent treatment the error message "arterial bubble sensor defective" appeared.Therefore the flow could not be measured, too.After replacement of the sensor the failure stayed.The whole device had to be replaced.No harm was reported.

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 # e2018002.Importer- maquet medical systems usa (b)(4).Contact person- (b)(6).The device was investigated by a service technician.Work performed on 2018-06-20.Report sent to dcu on 2018-06-29.Result of service order 42748850: the bubble sensor was already replaced by the customer.A functional test of the cardiohelp was performed.The failure could not be reproduced.According to email received on 2018-07-11 the ssu informed the dcu that the bubble sensor is not available for further investigation anymore.According to email received on 2018-07-19 the ssu informed the dcu that the device was sent to the customer.Log-files were not provided.The determination of the root cause is impossible due to missing data/material.Thus the failure could not be confirmed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.Since the reported failure did not contribute to a death or serious injury 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.

Event Description

Internal reference: (b)(4).

• Brand Name: MAQUET CARDIOHELP SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7446371
• MDR Text Key: 106255502
• Report Number: 8010762-2018-00146
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701048012
• Device Catalogue Number: 701048012
• Initial Date Manufacturer Received: 04/06/2018
• Initial Date FDA Received: 04/20/2018
• Supplement Dates Manufacturer Received: 04/06/2018
• Supplement Dates FDA Received: 07/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1