MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 701051696 - ROTAFLOW ENGLISH EU-PLUG ICU

Device Problem No Display/Image (1183)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 04/18/2020

Event Type  malfunction  

Manufacturer Narrative

A follow up medwatch will be submitted when additional information becomes available.

Event Description

It was reported that during device operation the flow measurement was not displayed.Complaint id: (b)(4).

Manufacturer Narrative

The reported failure "no flow is displayed" occurred during preparation and could be confirmed.According to the service report (b)(4) dated on the 2020-04-30 a maquet service technician confirmed that the flow was not displayed.The 701022754 ultrasonic contact cream was replaced.The rotaflow was tested and the flow can be displayed normally.Most probable root cause could be determined as: bubble/flow sensor failure, e.G.: * malfunction of bubble/flow sensor electronics; * dried contact gel; * user forgot renewing contact gel; * mechanical defects (impact); * sensor not detected although sensor is connected; * device used out of specification; * software error.The instruction for use (instructions for use | 4.2 | en | 13, chapter 2.2.4) states that: the ultrasonic contact cream can dry out and impair the functioning of the integrated flow/bubble sensor.In the "free" mode, the ultrasonic contact cream must be reapplied every 48 hours.Since the issue could be confirmed by a getinge employee, the failure could be confirmed.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaint id:(b)(4).

• Brand Name: HEART LUNG MACHINE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9994550
• MDR Text Key: 200776334
• Report Number: 8010762-2020-00137
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K991864
• 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: 05/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701051696 - ROTAFLOW ENGLISH EU-PLUG ICU
• Device Catalogue Number: 70105.1696
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1