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

Model Number ROTAFLOW

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2020

Event Type  malfunction  

Manufacturer Narrative

The reported failure "flow not measuring correctly" was discovered during patient treatment.The device was directly involved in the event and not able to meet its specifications.The failure could be confirmed.According to the service order (b)(4) dated on (b)(6) 2020 a getinge service technician confirmed that the flow rate was not measuring correctly.The 70107.3408 rotaflow (rf) icu push & rotary knob has been adjusted and set to zero.The flow of the rotaflow has been testes with a flow meter.The flow reading was also compared to two other rotaflow units and the flow was found to be comparable.The rotaflow passed the performance and safety test.The unit was approved for clinical user and returned to the costumer.According to the rotaflow risk analysis version v06 (dms# (b)(4)) reviewed on 2020-08-21 following possible root causes could be determined: malfunction of the flow measurement system: zero flow calibration failed.Incorrect flow measurement.Device used out of specification.Malfunction of the microcomputer system: failure on other device parts (rotary knob, display, etc).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

Customer reported that the flow rate was not measuring correctly.Upon arrival, i inspected the unit and did adjust the rpm/flow know to be set to zero.(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
• Manufacturer (Section G): NURSEL BOELENS; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; 4972229321
• MDR Report Key: 10435842
• MDR Text Key: 203810647
• Report Number: 8010762-2020-00266
• 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,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2020

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: ROTAFLOW
• Device Catalogue Number: 70104.3292
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 08/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2009
• 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