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

Model Number ROTAFLOW ENGLISH/US US-PLUG ICU

Device Problems No Display/Image (1183); Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Further information has been requested but has not yet been received.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

The event occurred in the us.It was reported that the error message ¿+5v test¿ was displayed and the lpm (liter per minute) are not displayed on the rotaflow console.The reported failure occurred during preparation of the device and no patient was involved.The device was not used for treatment.No harm to any person has been reported.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in the us.It was reported that the error message ¿+5v test¿ was displayed and the lpm (liter per minute) are not displayed on the rotaflow console.The reported failure occurred during preparation of the device and no patient was involved.The device was not used for treatment.No harm to any person has been reported.The rotaflow console with s/n (b)(6) was investigated by a getinge field service technician and the technician couldn't´t replicate the reported failure.As a precaution the rf (rotaflow) power supply pcba (printed circuit board assembly) (article number 701011675) has been replaced.Verified unit calibrated and passes all functional and safety tests per factory specifications, returned to customer and cleared for clinical use.Based on the investigation results the reported failure "+5v test error and lpm not displayed" could not be confirmed.However, the failure mode "lpm not displayed" can be linked to the following most possible root causes according to the rotaflow risk management file.Zero flow calibration failed, incorrect flow measurement, dried contact gel, user forgot renewing contact gel.The failure mode "+5v test error" can be linked to the following most possible root causes according to the rotaflow risk management file.Internal cpu failure, non-volatile memory failure, volatile memory failure, failure in safety relevant variables, time base failure, wrong supply, heat accumulation, device used out of specification.The review of the non-conformities was performed on 2022-12-06 and during the period of 2014-12-01 to 2022-12-06 does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.The rotaflow console in question was produced in 2014-12-01.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
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 15923074
• MDR Text Key: 306686110
• Report Number: 8010762-2022-00486
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW ENGLISH/US US-PLUG ICU
• Device Catalogue Number: 701051712
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1