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

Model Number 00175

Device Problems Particulates (1451); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

On (date unknown) at the (b)(6) it was reported that small red particles were found in the upper air vent of the arterial filter quart 00175.The filter is a part of the tubing set bo-hqv 14203.There was no patient involvement.(b)(4).

Manufacturer Narrative

(b)(4).Per the complaint closure letter dated august 10, 2013 wherein the investigation results are described, upon optical observation of the bleeder a scraping at the bottom area of the tap could be found.On closer examination of the tap seat in the housing lid and a deviation in the mass tolerance of the centering mandrel could be detected in addition to a sharp edge.A trend analysis was performed and the following causes were generation of the sharp edge in the housing cover by erosion the injection molding tool.Upper tolerance limit of the centering pin in the housing cover (diameter) resulting in the under pressurization of the vent valve.In the worst case, it is the combination of the two causes and the expansion of the seated under pressurized venting cock resulting from the temperature changes during the sterilization for shearing.Based on the above error analysis, two design changes were implemented: repair of injection mold the housing cover (polishing the mold contours).Adaptation of the outer diameter of the centering pin.(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: 4282884
• MDR Text Key: 5225078
• Report Number: 8010762-2014-00491
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K001787
• 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: 01/21/2013

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: 03/31/2013
• Device Model Number: 00175
• Device Catalogue Number: 70000.0175
• Device Lot Number: 70083528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2013
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/21/2013
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/21/2013
• Initial Date Manufacturer Received: 01/21/2013
• Initial Date FDA Received: 11/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2012
• 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