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

Model Number 70105.1712

Device Problems Premature Discharge of Battery (1057); Low Battery (2584)

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

Event Date 11/10/2012

Event Type  Injury  

Event Description

On (b)(6) 2012, rotaflow with serial number (b)(4) was in-use at university of maryland medical center when the unit lost battery power during the transport from the operating room (or) to the intensive care unit (icu).Hand cranking was performed.The unit was plugged in, inside the icu, then a back-up rotaflow console was used.No negative impact on the patient.(b)(4).

Manufacturer Narrative

(b)(4).Per service report (b)(4) that is associated with this complaint, testing was performed and the maquet sales and service unit (ssu) technician identified the battery needed replacing.The battery was replaced.Functional testing and safety check to factory specifications was performed.(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: 4519938
• MDR Text Key: 5406165
• Report Number: 8010762-2014-00660
• 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
• Type of Report: Initial
• Report Date: 11/12/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2015
• Is this an Adverse Event Report?: Yes
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/12/2012
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/12/2012
• Date Manufacturer Received: 11/12/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2010
• 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