MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HL-20 INTEGRATED PERFUSION SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number MCP00917751

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 04/06/2018

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

When on bypass the message "art stop" appeared on rotaflow.The sucker pumps of the hl20 caused the error on the rotaflow.The error can lead to a pump stop.No patient injury or harm reported.No information about pump stop or medical intervention received.(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 # e2018002.Importer- (b)(4).Requested information has not been received despite several requests.This complaint will be closed due to lack of information.The complaint will be re-opened if requested information or any new relevant information is received.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 this is a systemic error.No corrective action is needed.

Event Description

Internal reference: (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 # e2018002.Importer- maquet medical systems usa (b)(4).Contact person- (b)(6).A field service technician has been sent out for investigation on 2018-05-10 and stated that the device was tested for several hours, but the failure could not be reproduced.Thus the failure could not be confirmed.According to service order #(b)(4) dated on 2018-05-10 the technician tested the level sensor, checked the cables and connectors for failure.Full functional check and safety test performed.Device returned to clinical service.The service protocol has not been received despite several requests.This complaint will be closed without the service protocol.Therefore it cannot be assured in which technical status this device is currently.This complaint will be reopened and appropriate actions will then be taken if the service protocol is received and contains any further relevant information.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 this is a systemic error.No corrective action is needed.

Event Description

Internal reference: (b)(4).

• Brand Name: HL-20 INTEGRATED PERFUSION SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7443452
• MDR Text Key: 106157241
• Report Number: 8010762-2018-00142
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2018

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: MCP00917751
• Device Catalogue Number: 701028581
• Initial Date Manufacturer Received: 04/06/2018
• Initial Date FDA Received: 04/19/2018
• Supplement Dates Manufacturer Received: 04/06/2018; 04/06/2018
• Supplement Dates FDA Received: 05/08/2018; 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1