MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG CARDIOHELP SYSTEM; HEART-LUNG,CARDIOPULMONARY BYPASS

Model Number 70104.8012

Device Problems Out-Of-Box Failure (2311); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 10/10/2012

Event Type  malfunction  

Event Description

On (b)(6) 2012, the maquet technician reported an out of box failure for cardiohelp (serial number (b)(4)) at (b)(6).According to the technician, while performing the battery calibration the unit failed the battery calibration.The battery calibration was performed again and passed.However, the self-test failure report displayed "digital io" message.There was no patient involvement.(b)(4).

Manufacturer Narrative

(b)(4).On 12/18/2012, correspondence was sent to the sales and service unit (ssu) regarding this complaint event.Per correspondence, this failure is related to the rotary knob.If the error is reproducible, check the rotary knob or change the human machine interface (hmi).(b)(4).

• Brand Name: CARDIOHELP SYSTEM
• Type of Device: HEART-LUNG,CARDIOPULMONARY BYPASS
• 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: 4279811
• MDR Text Key: 5035404
• Report Number: 8010762-2014-00653
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133598
• 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: 10/10/2012

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: 70104.8012
• Device Catalogue Number: 70104.8012
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/10/2012
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/10/2012
• Initial Date Manufacturer Received: 10/10/2012
• Initial Date FDA Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• 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