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

Model Number RPM 20-320

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 03/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).Investigation by field service technician has been performed on 2018-03-30.According to service report: the failure could be duplicated.Service troubleshot system and determined the motor assembly is in need of replacement - ( dust particles all on bottom of unit ).Device has been returned to ssu workshop for repair.A supplemental medwatch will be submitted after new information has been received.

Event Description

Customer stated the single pump would display a runaway error when initiated.Error occurred prior to use.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).Rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption #(b)(4).Importer- maquet medical systems usa (b)(4).Contact person-(b)(6).Further investigation/repair performed by mahwah repair center on(b)(6)2018 and(b)(6)2018.According to service report: runaway error message when rpm is increased - replace motor and belts.Pm, calibration and full functional test as per the service manual.All tests passed.Thus the failure could be confirmed.As confirmed by the field service technician on (b)(6)2018, the defective motor is a parvex motor.This type of motor is old and has already been replaced by new motor from another manufatured which are now beeing used.Further investigation not necessary.The data is also being handled through a designated maquet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: 7432862
• MDR Text Key: 105881408
• Report Number: 8010762-2018-00134
• 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
• Report Date: 06/04/2018

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: RPM 20-320
• Device Catalogue Number: MCP00702885
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/30/2018
• Initial Date FDA Received: 04/16/2018
• Supplement Dates Manufacturer Received: 03/30/2018
• Supplement Dates FDA Received: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1