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

Model Number CARDIOHELP-I

Device Problem Communication or Transmission Problem (2896)

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

Event Date 06/14/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported, that the flow/bubble sensor worked intermittent during treatment without harm for the patient.The dhr of the cardiohelp (material: 70104.8012, serial: (b)(4) for which a customer complaint was received, was reviewed on 2019-10-17.The dhr does not show any abnormality or issue that is related or can have led to the customer complaint.Under the service protocol from (b)(6) 2019 the service technician from ssu-us (sale and service unit) stated that the flow/bubble sensor is defective and needs to be replaced.Maquet gmbh requested the product in question for further investigation in the laboratory of the manufacturer on 2019-11-04.The returned product was received by the manufacturer on 2019-12-23.The flow/bubble sensor was investigated by life cycle engineering (lce) on 2020-04-29.As stated in the investigation report the malfunction could be confirmed.The complained flow-/bubble-sensor (fbs) is not recognized by the reference cardiohelp and is to be assessed as defective.Thus the reported failure could be confirmed.To determine the cause of failure, the fbs was sent to the manufacturer em-tec gmbh with the request for a thorough investigation (rma2020-10108).If significant information becomes available out of the supplier investigation this complaint will be reopened and necessary actions will be implemented.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonarys trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Reporting decision re-evaluated: a "flow/bubble sensor defective" error was reported.Issue occurred during patient treatment.No indication of actual or potential for harm or death.Complaint number: (b)(4).

• Brand Name: CARDIOHELP
• 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: 12347052
• MDR Text Key: 267423972
• Report Number: 8010762-2021-00468
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/20/2021

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: CARDIOHELP-I
• Device Catalogue Number: 701048012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 08/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2018
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1