MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLS-7.0

Lot Number 70080506

Device Problems Increase in Pressure (1491); Obstruction of Flow (2423)

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

Event Date 02/11/2013

Event Type  Injury  

Event Description

The customer stated that during operation of the hls 7.0 on a cardiohelp console, that he noticed the transmembrane pressure (delta p) of the hls increase to around 200 mmhg.Additionally, the customer stated the po2 was 150 mmhg was pco2 was rising contrary to elevated sweep gas.The hls was changed out as they felt a clot was present in the circuit.The customer also stated that the act had fallen to about 150 sec during the support period.(b)(4).

• Brand Name: HLS-7.0
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 4365258
• MDR Text Key: 5288383
• Report Number: 3008355164-2014-00311
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/11/2014,02/11/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 70080506
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/11/2013
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2013
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention