MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH ROTAFLOW CENTRIFUGAL PUMP SYSTEM; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 701051713 - ROTAFLOW EN/NORTH AM US-PLUG ICU

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.Device not returned not eval.

Event Description

While supporting a patient on a rotaflow the pump suddenly was unable to go above 900 rpms.This caused the nurse to hand crank until perfusion arrived.Once perfusion arrived they rebooted the unit and the problem resolved.No harm to the patient.Complaint# (b)(4).

Manufacturer Narrative

The initial failure description was that while supporting a patient on a rotaflow the pump suddenly was unable to go above 900 rpms.The service order has not been received despite several requests.This complaint will be closed without the service order.Therefore it cannot be assured in which technical status this device is currently.This complaint will be reopened and appropriate actions will then be taken if the service order is received and contains any further relevant information.Thus the reported failure could not be confirmed and a most probable root cause could not be determined.The failure occurred during supporting a patient and therefore a relationship between the device and the complaint is given.The occurence rate is below the acceptance rate, thus no remedial action required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaint number: (b)(4).

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9080699
• MDR Text Key: 199892611
• Report Number: 8010762-2019-00287
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701051713 - ROTAFLOW EN/NORTH AM US-PLUG ICU
• Device Catalogue Number: UNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/18/2019
• Supplement Dates Manufacturer Received: 01/08/2020
• Supplement Dates FDA Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1