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

Model Number 70104.3290

Device Problem No Display/Image (1183)

Patient Problem No Information (3190)

Event Date 01/30/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014 at the (b)(6) it was reported that after 1-3 hours of operation, the flow (lpm) was not displayed on the rotalfow console serial number (b)(4).(b)(4).

Manufacturer Narrative

Maquet medical system, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).The device was evaluated by the (b)(4) and the battery module was found to be defective and was replaced.(b)(4).

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4931843
• MDR Text Key: 6015251
• Report Number: 8010762-2015-00601
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/04/2014

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: 70104.3290
• Device Catalogue Number: MCP00706037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/04/2014
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2014
• Initial Date Manufacturer Received: 02/04/2014
• Initial Date FDA Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2011
• 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