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

Model Number 701051699 - ROTAFLOW FRENCH EU-PLUG ICU

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 05/07/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported by the costumer that the zero flow calibration of the rotaflow failed and in addition the error message "com err" was displayed.(b)(4).

Manufacturer Narrative

The failure "0 flow calibration failed + com error" was reported by the costumer at the (b)(6).The device was directly involved in the incident.According to the service report (b)(4) dated on 2020-05-19 the reported failure "0 flow calibration failed + com error" could not be confirmed.The 701011681 flow measurement board was replaced as a precaution.The functionality test and electrical test of the rotaflow were passed and the device was returned for clinical use.The rotaflow risk analysis version 06 (dms#(b)(4)) chapter h1.1.1.35 + h1.1.1.3 was reviewed on 2020-05-08 with the following outcome: the most possible root cause for the reported failure "0 flow calibration failed" 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 most possible root cause for the reported failure "com error" could be determined as: un)intentional stop of the pump, e.G.: * defective motor control electronics* pump stop intervention after technical error (e.G.Pump runaway, error head); * sensor error (bubble, level, pressure(in hl20 mode), flow); * software error; * wrong intervention limits; * unintended rpm change by user; * unintended switch off by user; * freeze of microcontroller sab80c517; * defect of micro controller pici 14000; * defect of transformer; * defect of internal power supply (dc/dc).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
• MDR Report Key: 10057045
• MDR Text Key: 192169070
• Report Number: 8010762-2020-00162
• 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: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701051699 - ROTAFLOW FRENCH EU-PLUG ICU
• Device Catalogue Number: 701051699
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1