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

Model Number MCP00917751

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 11/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A supplemental medwatch will be submitted after receipt of additional information.

Event Description

Bubble detector is faulty.No patient involved.(b)(4).

Manufacturer Narrative

Customer reported that during pretesting, no patient involvement, that bubble sensor not working.According to service order no.(b)(4) maquet engineer replaced with spare bubble sensor, installed new one and returned spare sensor to staff.Old bubble sensor disposed of by customer.Unit passed all functional and safety tests per factory specifications, returned to customer and cleared for clinical use.As the replaced bubble sensor is not available for laboratory investigation, exact root cause could not be determined.A similar complaint with similar malfunction has been investigated previously with following complaint: (b)(4).According to quotation from the supplier of the bubble sensor- em tech # (b)(4), if the following has been performed: em-tec confirmed the problem.The connection cable is mechanically broken on both cable glands.As a result, a number of strands within the cable are torn and lead to failure.

Event Description

Reference no.(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
• 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: 7059544
• MDR Text Key: 93564529
• Report Number: 8010762-2017-00370
• 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: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2017
• 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