MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUART ARTERIAL FILTER, MODEL HBF 140; FILTER, BLOOD, CPB, ARTERIAL LINE

Model Number HBF-140 J

Device Problems Particulates (1451); Out-Of-Box Failure (2311); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 08/21/2012

Event Type  malfunction  

Event Description

On (b)(6) 2012 at (b)(6) hospital in (b)(6), it was reported that a red particle was found in the arterial filter quart hbf-140 j during priming procedure.There was no patient involvement.(b)(4).

Manufacturer Narrative

(b)(4).Per the final statement to complaint letter dated march 11, 2013 the foreign particulate matter originated from an abrasion of the red stopcock.Manufacturing identified the root cause and polished the molding tool to cease abrasion.A diameter reduction of the stopcock holder has been implemented to cease further red particulate matter.(b)(4).

• Brand Name: QUART ARTERIAL FILTER, MODEL HBF 140
• 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: 4282879
• MDR Text Key: 5299611
• Report Number: 8010762-2014-00461
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K001787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/27/2012

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: 10/31/2013
• Device Model Number: HBF-140 J
• Device Catalogue Number: 70103.1617
• Device Lot Number: 70073145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2012
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/27/2012
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2012
• Initial Date Manufacturer Received: 08/27/2012
• Initial Date FDA Received: 11/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1