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

Model Number BO-00175

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 09/21/2011

Event Type  malfunction  

Event Description

On (b)(6) 2011 at the (b)(6), it was reported that the housing of the arterial filter quart bo-00175 had a crack.There was no patient involvement.Reference: (b)(4).

Manufacturer Narrative

Maquet medical system, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).Per the laboratory evaluation report dated february 13, 2012 visual inspection of the returned sample was performed which confirmed that there was a crack at the luer lock of the vent stop cock.The root cause could not be determined but transport damage or stress on the part were stated as probable causes.100% leak testing and visual inspection of the part is performed in the assembly process.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: 4282764
• MDR Text Key: 5299124
• Report Number: 8010762-2014-00377
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/07/2011

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: 10/30/2011
• Device Model Number: BO-00175
• Device Catalogue Number: 70103.2031
• Device Lot Number: 70065808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2012
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/07/2011
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2011
• Initial Date Manufacturer Received: 10/07/2011
• Initial Date FDA Received: 11/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2011
• 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