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

Model Number CARDIOHELP-I

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

Failure code 0x22003.Device shut down.After that the patient was supported with the emergency drive.Patient was not injured.(b)(4).

Event Description

Sap#: (b)(4).

Manufacturer Narrative

According to the service report we received from our service technician on 2019-06-27.He troubleshot the device and could confirm the reported failure.He checked the device and found the hmi board and the sensor panel being defective and replaced them.After that full functional test and cleaning was performed.Device is working to factory specification and is back in clinical use.The reported failure is covered in our risk analysis document under risk id: h1.1.3.2 and most possible root cause for the reported failure could be determined to defective hmi board and defective sensor bridge leading to battery failure.Thus the reported failure can be confirmed.Further the device history record (dhr) of the concerned cardiohelp (material: 70104.8012, serial: (b)(6) was reviewed on 2019-08-13.The dhr does not show any abnormality or issue that is related or can have led to the customer complaint.The ocurrance rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

• Brand Name: CARDIOHELP SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 8207985
• MDR Text Key: 131919510
• Report Number: 8010762-2019-00001
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• 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?: Yes
• Date Manufacturer Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1