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

Model Number HBF-140 U

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

On (date unknown) at the (b)(6), it was reported that two units from the same lot of the arterial filter quart hbf-140 were leaky.Note: this mfr report number is being submitted for the second unit.Mfr #8010762-2014-00385 was submitted for the first unit.(b)(4).

Manufacturer Narrative

(b)(4).Per the laboratory evaluation reported dated (b)(4) 2011 wherein leakage testing was performed, it was confirmed that there was a leak in the filter housing at the venting valve.The root cause could not be determined but under certain conditions stress within the material can result in leakage in the housing.100% leak testing and visual inspection of the part is performed in the assembly process.(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: 4282844
• MDR Text Key: 5030992
• Report Number: 8010762-2014-01061
• 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: 11/16/2011

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: 09/30/2012
• Device Model Number: HBF-140 U
• Device Catalogue Number: 70100.4264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2011
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/16/2011
• Device Age: 14 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2011
• Initial Date Manufacturer Received: 10/16/2011
• Initial Date FDA Received: 11/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2010
• 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