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

Model Number 701022161 - ROTAFLOW DRIVE UNIT, BLUE

Device Problem No Flow (2991)

Patient Problem No Patient Involvement (2645)

Event Date 05/18/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported from (b)(6) that in the routine recall, install the spare rotaflow drive to the customer sn: (b)(4).After the installation is complete, the machine intelligently displays the speed and cannot display the flow rate, but the original machine's drive pump head flow rate is normal, so it is determined that the rotaflow drive is defective.Complaint id: (b)(4).

Event Description

Complaint id:(b)(4).

Manufacturer Narrative

Initially it was reported that on the rotaflow no flow was displayed.A getinge field service technician investigated the device in question.According to the communication grid from the getinge field service technician dated on (b)(6)2020 no flow displayed could be confirmed and the drive was replaced with new drive with s/n 910118929.Refer to communicatin grid in the complaint dated on (b)(6)2020 the customer received the new drive with s/n (b)(6).Due to import restrictions in china the repair of the rotaflow drive cannot be performed at manufacturer's (em-tec) site.The customer received a replacement drive.The rotaflow risk analysis version v06 (dms# 2023689) chapter h1.1.1.35 was reviewed on (b)(6)2020 with the following outcome: the most possible causes for the reported failure "no flow displayed" could be determined as: malfunction of the flow measurement system: * zero flow calibration failed * incorrect flow measurement * device used out of specification * software error the reported failure "no flow displayed" was detected in the rountine call of the drive 910117238 and could be confirmed.The device was directly involved in the incident.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.

• 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: 10074498
• MDR Text Key: 191615330
• Report Number: 8010762-2020-00171
• 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: 06/25/2020

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: 701022161 - ROTAFLOW DRIVE UNIT, BLUE
• Device Catalogue Number: 701022161
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/18/2020
• Initial Date FDA Received: 05/20/2020
• Supplement Dates Manufacturer Received: 06/23/2020
• Supplement Dates FDA Received: 06/25/2020
• Patient Sequence Number: 1