MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number HL 20

Device Problem Pumping Problem (3016)

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

Event Date 02/09/2024

Event Type  malfunction  

Event Description

The event occurred in india during a routine check.It was reported that the error message "safety-s" was displayed on a hl20 pump.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in india during a routine check.It was reported that the error message "safety-s" was displayed on a hl20 pump.No harm to any person has been reported.A getinge field service technician will be sent onsite for investigation of the device.As soon as new information becomes available a follow up medwatch will be submitted.

Manufacturer Narrative

It was reported that the error message "safety-s" was displayed on a hl20 pump.The event occurred during a routine check.No harm to any person has been reported.A getinge field service technician (fst) was sent for investigation and repair on 2024-03-19.All the connectors and boards were cleaned and refitted.No parts were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.A similar case was assessed by the getinge life cycle engineering on 2024-03-04.Because the error "safety-s" was resolved by refitting of all circuit board connections the most probable root cause was determined as communication disturbances due to transition resistance that can arise from surface corrosion.The review of the non-conformities has been performed on 2024-04-04 for the period of 2014-11-20 to 2024-02-09.It 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 device was manufactured on 2014-11-20.Based on the results the reported failure "error message safety-s" could be confirmed.The customer will be informed about the results by the getinge sales and service unit.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: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• 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: 18777151
• MDR Text Key: 336333534
• Report Number: 8010762-2024-00105
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL 20
• Device Catalogue Number: 70102.8580
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/18/2014
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1