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

Model Number MCP00706187

Device Problem Device Inoperable (1663)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).As stated by the hospital, a working bubble module was pulled from a second hl20 (mcp00917741#hl 20, 4-pumps console base, article number 70102.8580, serial number (b)(4)) to replace the defective bubble module on the affected hl20.The hospital has been doing their own service.No maquet technician was involved in this case or even alerted to the fact that this incident occurred.Thus the failure could not be confirmed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.No additional investigation will be performed.

Event Description

It was reported that the bubble module (mcp00924141#apm 20-411, article number 70101.7276, serial number (b)(4)) on a hl20 failed again - center led`s remain on and alarm will not clear.(second event).No known consequences to patient.(b)(4).Related to complaint internal reference- (b)(4) - first event.

Manufacturer Narrative

Affected module:mcp00924141#apm 20-411.Articel number:70101.7276.Serial number:(b)(4).The unit was investigated by clinical engineering.The problem could be duplicated.The hospital has been doing their own service.A replacement, working, module was taken from a different hl20 (mcp00917741#hl 20, 4-pumps console base, article number 70102.8580, serial number (b)(4)).Replacement was done by clinical engineering.It was completed prior to the start of the case.Corrected data: due to the fact that investigation/service was done by clinical engineering, trained on maquet products, the failure could 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.

Event Description

(b)(4).

• Brand Name: MAQUET HL-20 INTEGRATED PERFUSION SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 5547560
• MDR Text Key: 42517060
• Report Number: 8010762-2016-00241
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2016

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: MCP00706187
• Device Catalogue Number: 701043253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2016
• Initial Date FDA Received: 04/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/02/2016
• Date Device Manufactured: 06/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1