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

Model Number ROTAFLOW PUMP MODUL

Device Problems Self-Activation or Keying (1557); Improper Device Output (2953)

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

Event Date 11/25/2015

Event Type  Injury  

Manufacturer Narrative

December 21, 2015 02:08 pm (gmt-5:00) added by (b)(6): (b)(4).A maquet field service technician evaluated the device it was found that the flow reading changed when the drive cable was moved at the input connector on the console.The service technician tested it with another known good drive and confirmed the problem located in the console.The console will be shipped to the factory depot for repair.(b)(4).A supplemental report will be provided when additional information becomes available.

Event Description

It was reported that during use/procedure the perfusionist found that the flow reading was changing while rpm's (revolution per minute) stayed constant.It was reported, that an external flow monitor was connected for the rest of the case.The flow monitor confirmed that the rotaflow readings were incorrect (up to 1 liter difference).No reported no adverse effect to the patient.Additional information, received 2015-12-03: the unit was being used in free mode.It was also reported, that there were no obstructions.(b)(4).

Manufacturer Narrative

A maquet field service technician evaluated the device.The failure was confirmed.It was determined that the failure is caused by a defect on the "lemo"-rotaflow-drive-master-connector and the cable assembly.The "lemo"-rotaflow-drive-master-connector and the cable assembly was replaced.Preventive maintenance, functional test and safety check according to the service manual was successfully performed.The replaced parts were requested by the manufacturer for further investigation.A supplemental report will be provided if additional information becomes available.

Event Description

(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 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; 4972229321
• MDR Report Key: 5324068
• MDR Text Key: 34272880
• Report Number: 8010762-2015-01281
• 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,Followup
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW PUMP MODUL
• Device Catalogue Number: 701043292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/30/2015
• Device Age: 6 YR
• Event Location: Home
• Date Report to Manufacturer: 11/30/2015
• Date Manufacturer Received: 04/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR