MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HL 20 LEFT ORIENTED CON, 5-PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number LOC 20-150

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 01/29/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).The field service technician (fst) was on-site for further investigation.According to the service report# (b)(4) dated on 2019-01-29 following was found: the customer stated the level sensor was non functional during setup.The fst observed the system and replaced the capacitive level sensor 20-535 (material# 701010855, lot# 104035) and backup sensor as per the request of the customer.Unit passed all calibration, functional and safety tests performed.Unit was returned to customer and cleared for clinical use.Final result of investigation/ probable root cause determination is pending.A supplemental medwatch will be submitted after new information has been received.

Event Description

It was stated that the hl 20 the level sensor was non functional during setup.No patient involvement was stated.(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).The defective level sensor is no more available for further investigation since the customer already scrapped it.However, the field service technician confirmed that the cable was pinched by the customer causing the sensor to be non functional.Thus the failure could be confirmed, but no product related malfunction.The most probable root cause could be determined as mishandling/user error.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 LEFT ORIENTED CON, 5-PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 8350011
• MDR Text Key: 140010936
• Report Number: 8010762-2019-00039
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K991864
• 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: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LOC 20-150
• Device Catalogue Number: MCP0.0702611
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1