MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH MAQUET CARDIOHELP 7.0; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number HLS 7.0

Device Problem Defective Component (2292)

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

Event Date 11/20/2020

Event Type  Injury  

Event Description

The cardiohelp hls 7.0 ecmo system manufactured by maquet displayed and sounded an advisory alarm "pressure drop out of range".Upon investigation, it was found that the p(int) pressure sensor was displaying -500mmhg when normally it should be a positive number.P(art), p(ven) and flows were normal and the patient continued to be supported.Due to intermittent advisory alarm, we had to briefly discontinue support and "zero" the sensor.Upon reinitiating support, p(int) was displaying "0", p(art) was displaying 213mmhg and delta p was displaying -213mmhg.We left the upper range for delta p at -180mmhg for clinical intervention and continued support without further events.Fda safety report id# (b)(4).

• Brand Name: MAQUET CARDIOHELP 7.0
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH
• MDR Report Key: 10903305
• MDR Text Key: 218517826
• Report Number: MW5098085
• Device Sequence Number: 1
• Product Code: DTQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2022
• Device Model Number: HLS 7.0
• Device Catalogue Number: BEQ-015703112
• Device Lot Number: 70138141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 92