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

Model Number 70104.6577

Device Problem Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 10/07/2012

Event Type  malfunction  

Event Description

On (b)(6) 2012, (b)(6) identified that abnormal sounds were being emitted from hls circuit (lot number 70075070).(b)(4).

Manufacturer Narrative

(b)(4).The sample was returned for complaint evaluation.An evaluation was performed on the complaint sample and it was determined that the complaint condition could not be confirmed.The sample was tested at 0.5 l/min, 2 l/min, 4 l/min, and 7 l/min and no noises were identified.(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: 4278525
• MDR Text Key: 21878052
• Report Number: 8010762-2014-01260
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/08/2012

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 Expiration Date: 07/31/2012
• Device Model Number: 70104.6577
• Device Catalogue Number: BE-015703112
• Device Lot Number: 70075070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2012
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2012
• Initial Date Manufacturer Received: 10/08/2012
• Initial Date FDA Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1