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 Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 04/23/2013

Event Type  malfunction  

Event Description

On (b)(6) 2013 at the (b)(6) hospital in (b)(6) it was reported that leakage of the priming liquid was seen from the part of the housing near the purge valve of the arterial filter quart bo-hbf 140-j as soon as priming was started.There was no patient involvement.Reference: complaint (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 final statement dated september 12, 2014 visual inspection and leakage testing was performed on the returned sample and it was confirmed that there was a crack in the housing near the purge valve.The pictures indicated that a potential excessive or inadequate external force was exerted on the bypass cock by another object which resulted in material fracture.Leakage testing confirmed leakage at the housing near the red stop cock caused by a crack.A device history record and batch record review was performed and no abnormalities were found.Such leakages would be clearly detected in the 100% function test in production, however, it is possible that the crack could appear later on due to impact from a hard object used to eliminate air bubbles from the filter.Another possible cause is influence of heat in combination with a too strong fit of the red stop cock in the housing.Reference: complaint (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: 4282886
• MDR Text Key: 5225079
• Report Number: 8010762-2014-00496
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/01/2013

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: 12/31/2014
• Device Model Number: BO-HBF 140-J
• Device Catalogue Number: 70104.8784
• Device Lot Number: 70084068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2013
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/01/2013
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2013
• Initial Date Manufacturer Received: 05/01/2013
• Initial Date FDA Received: 11/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2012
• 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