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

Model Number BO-HBF 140-J

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 01/28/2013

Event Type  malfunction  

Event Description

On (b)(6) 2013, at (b)(6), during priming, a red piece of plastic, was found at the purge port of lot 70080306.(b)(4).

Manufacturer Narrative

(b)(4).The quart arterial filter was returned to maquet (b)(4) and analyzed.It was determined that the reason for the foreign particle was an abrasion of the red stopcock.The foreign particle can be caused by heat influences in combination with a burr in the molding tool.As a corrective action, production was notified of this event.Production has since polished the molding tool.(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: 4282862
• MDR Text Key: 5225076
• Report Number: 8010762-2014-00492
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K090518
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/19/2013

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: Other
• Device Expiration Date: 05/31/2014
• Device Model Number: BO-HBF 140-J
• Device Catalogue Number: 70104.8784
• Device Lot Number: 70080306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2013
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/19/2013
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/19/2013
• Initial Date Manufacturer Received: 02/19/2013
• Initial Date FDA Received: 11/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2012
• 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