MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG ROTAFLOW CENTRIFUGAL PUMP SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number ROTAFLOW CONSOLE

Device Problems Premature Discharge of Battery (1057); Loss of Power (1475)

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

Event Date 03/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The manufacturer requested additional information on the reported event, including the product details.Unfortunately no information could be obtained so far.Based on the information available to the manufacturer at this time the health care professional at the hospital noticed the reported battery capacity problem during the set-up of the device and still decided to use the device, supported by an external battery supply.Based on this information the user used the device outside the intended use specified in the instructions provided by the manufacturer (ifu), in modifying the system by connecting an external portable battery supply which is not part of the approved system.The following instructions are provided within the ifu: "only attach the intended components to the rotaflow console.To ensure patient safety, only use tested and approved devices, parts, accessories, and disposables.Take damaged devices out of service immediately and have them tested by the authorized service personnel.The operator is not permitted to change or modify the device.Do not connect equipment which does not form part of this system." a supplemental report will be provided if additional information becomes available.

Event Description

It was reported that while setting up the rotaflow the user noticed upon unplugging the unit, the battery would not hold power and the unit shut off.The account plugged the unit into a portable battery which allowed them to transport the patient within the hospital.The unit, is in use and continues to be in use.(b)(4).

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 5573993
• MDR Text Key: 43171106
• Report Number: 8010762-2016-00258
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW CONSOLE
• Device Catalogue Number: 701043292
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1