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

Catalog Number MCP0.0702885

Device Problem No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).Service observed the system and determined the motor and-or cam assembly was in need of replacement.During troubleshooting the belts were replaced due to broken belt.

Event Description

As stated by the customer: "the pump would display a beltslip error at power during a setup." 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).Investigation: service observed the system and determined the motor and-or cam assembly was in need of replacement.During troubleshooting the belts were replaced due to broken belt.The device was returned to national repair center mahwah.According to the service report, the service team in mahwah found a worn tacho strobe, which has to be replaced.Thus the failure could be confirmed.Root cause could be determined as worn tacho strobe.As stated by the ssu technician the defective parts are no longer available for return.Since the parts are not available for return, further investigation has not been performed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further iinvestigation initiations will be completed at this time.Correction: according to the service report the worn tacho strobe (701007785 mcp00923311#tacho strobe rpm) has been replaced.Pm, calibration and full functional test as per the service manual were performed.All tests passed.Corrective action: 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: 8170313
• MDR Text Key: 130659444
• Report Number: 8010762-2018-00330
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/28/2019

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 Catalogue Number: MCP0.0702885
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 12/17/2018
• Supplement Dates Manufacturer Received: 12/06/2018
• Supplement Dates FDA Received: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1