MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET CARDIOHELP

Model Number 70104.8012

Device Problems No Audible Alarm (1019); Improper Alarm (2951)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/05/2014

Event Type  Injury  

Event Description

It was reported that a pt was on veno-veno extracorporeal life support, when they noticed air infiltrating on the arterial side of the circuit.It was noted that the bubble detector was not detecting the infiltrating air.Prior to using the cardiohelp it was mentioned that the pt's venous pressures where in-appropriate after the calibration, so a separate venous pressure transducer was tethered to the cardiohelp disposable circuit to monitor pressures.Since the bubble detector was not detecting what appeared to be air entering the system, the decision was made to swap the unit and the disposable.No pt effect was reported.(b)(4).Ref.Mfr # 8010762-2014-00220.

• Brand Name: MAQUET CARDIOHELP
• Type of Device: CARDIOHELP
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET MEDICAL SYSTEMS USA; 45 barbour pond drive; wayne NJ 07470 000
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470-0000
• MDR Report Key: 3882981
• MDR Text Key: 21803515
• Report Number: 3008355164-2014-00108
• Device Sequence Number: 1
• Product Code: DTQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/29/2014,05/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70104.8012
• Device Catalogue Number: 70104.8012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/06/2014
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Weight: 44