MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG ROTAFLOW; ROTAFLOW ENGLISH/US ICU

Model Number 70105.1712

Device Problems Low Battery (2584); Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Date 11/27/2013

Event Type  Death  

Event Description

It was reported that during a critical care transport to the operating room, there was a low battery alarm on the rotaflow, then a slight 5 minute delay and the battery went dead.Two perfusionist's were present during the transport and hand cranked to the cardiovascular operating room.The patient was maintained on full ecmo support during the event.Power was connected in the operating room where they had to re-cannulate the patient.At that time, they switched to a new pump and new circuit with the connection to new cannulas.The original pump was then quarantined and tested by the facility.The pump would hold a charge to 22.5 - 23.2 and run on battery with full rpm load for approximately 20 minutes.At some point after the surgery the family electively withdrew support and the patient expired.The customer has indicated that the event did not cause or contribute to the patient outcome.(b)(4).

• Brand Name: ROTAFLOW
• Type of Device: ROTAFLOW ENGLISH/US ICU
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 3569925
• MDR Text Key: 4053117
• Report Number: 3008355164-2014-00001
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/06/2014,12/07/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70105.1712
• Device Catalogue Number: 70105.1712
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/07/2013
• Event Location: Hospital
• Date Report to Manufacturer: 12/12/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other