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

Model Number MCP00703323

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4) as stated on 2018-04-02 by the field service technician the device has been investigated and it has been found a broken safety system board ((b)(4)).

Event Description

As stated by the customer: "err safety-s" occurred, while the second pump of twin pump was switched on.Switched off this pump, and turned the pump head manually.Then turned on this pump, same error.Error occurred on startup of device.No patient involvement.(b)(4).

Manufacturer Narrative

Maquet medical systems, usa (importer) submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption#: (b)(4).Importer: (b)(4).Contact person: (b)(6).As stated by the field service technician the device has been investigated and it has been found a broken safety system board (material#: 70100.7756, serial number: (b)(4).The safety system board has been replaced.After replacement of the board the error did not reoccur, the pump is working properly.The broken safety system board was returned for further investigation at maquet laboratory(life cycle engineering: (b)(6).According to investigation report, signed on 2018-08-02 by (b)(6), the failure "err.Safety-s" could be reproduced.Thus the failure could be confirmed.Most probable root cause could be determined as a defective circuit board.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.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.

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: 7428252
• MDR Text Key: 105666771
• Report Number: 8010762-2018-00133
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/07/2018

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: MCP00703323
• Device Catalogue Number: 701035075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Initial Date Manufacturer Received: 03/20/2018
• Initial Date FDA Received: 04/13/2018
• Supplement Dates Manufacturer Received: 03/20/2018
• Supplement Dates FDA Received: 08/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1