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

Model Number 70105.1712

Device Problems Loss of Power (1475); Low Battery (2584)

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

Event Date 07/25/2013

Event Type  malfunction  

Event Description

On (b)(6) 2013, at (b)(6) hospital, a rotaflow (english us/us-plug unit material number 70105.1712, serial number (b)(4)) was plugged in for "several" days and the perfusionist unplugged it to take it down to put on a patient.Within thirty seconds of use, the low battery alarm went off and the unit shut off within two minutes.A back up rotaflow was used without incident.(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 a ssu technician and it was found that the charging voltage was 31.21 volts.The battery was slow to recharge after a 15 minute test and it would start dropping voltage immediately after ac was removed.The battery pack was also past due for replacement and was therefore replaced.The device was tested to factory specifications and passed all tests.(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: 4938019
• MDR Text Key: 6255131
• Report Number: 8010762-2014-00882
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/25/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• Is this an Adverse Event Report?: No
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/25/2013
• Device Age: 22 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2013
• Date Manufacturer Received: 07/25/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2011
• 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