MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUART ARTERIAL FILTER WITH SOFTLINE COATING; FILTER, BLOOD, CPB, ARTERIAL LINE

Model Number BO 00175

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 01/20/2012

Event Type  malfunction  

Event Description

On (b)(6) 2012 at the (b)(6) it was reported that the arterial filter quart bo-00175 leaked during priming and was replaced.There was no patient involvement.(b)(4).

Manufacturer Narrative

(b)(4).No sample was returned and hence no evaluation was performed.Reference: (b)(4).

• Brand Name: QUART ARTERIAL FILTER WITH SOFTLINE COATING
• Type of Device: FILTER, BLOOD, CPB, ARTERIAL LINE
• 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 ; maquet medical system, usa; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4283038
• MDR Text Key: 5298199
• Report Number: 8010762-2014-00403
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K090518
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/20/2012,02/20/2012

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: 11/30/2010
• Device Model Number: BO 00175
• Device Catalogue Number: 70103.2031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/20/2012
• Device Age: 21 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/20/2012
• Initial Date Manufacturer Received: 01/20/2012
• Initial Date FDA Received: 11/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2010
• 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