MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 701035075 - HL 20

Device Problem Pumping Problem (3016)

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

Event Type  malfunction  

Manufacturer Narrative

A supplemental medwatch will be submitted after new information has been received.

Event Description

It was stated that the hl20 pump displayed the error "err head".(b)(4).

Manufacturer Narrative

The reported failure was head error.The pump has been sent for repair (rma#40050).The device was received in mcp service on 2020-02-12 for investigation.2020-02-20: the device was investigated by mcp service as follows: the pump was operated overnight and the reported failure "head error" could be confirmed.When the head was turned slowly by hand then you could feel and hear something rubbing and vibration in the pump head.This is probably a defective bearing as the left pump head has none of these signs and turns completely silent and vibration-free.New pump head must be ordered.The most probable root cause could be determined as a defective bearing on the pump head.Thus the reported failure "head error" could be confirmed.The device has been taken out of use.Clarification if repair or replacement will be done by the customer.The reported failure "head error" did not happen during patient treatment.The hl20 in question was responsible for this complaint/event.The occurrance rate is below the acceptance rate, thus no remedial action required.The ocurrance rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaint #(b)(4).

• Brand Name: HEART LUNG MACHINE
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9537745
• MDR Text Key: 199252743
• Report Number: 8010762-2020-00003
• 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: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

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: 701035075 - HL 20
• Device Catalogue Number: MCP00703323
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 01/02/2020
• Supplement Dates Manufacturer Received: 02/20/2020
• Supplement Dates FDA Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1