MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG BE-FLS 2050#PERMANENT LIFE SUPPORT SET; TUBING SET

Catalog Number 70102.7818

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 11/03/2014

Event Type  malfunction  

Manufacturer Narrative

Maquet cardiopulmonary ag will not be able to obtain the product back for investigation, for the product was discarded by the hosp.Therefore, we will not be able to confirm the failure.Based on the failure description received from the hosp, the most probable root cause is delamination of some gas fibers from the polyurethane potting area.Maquet cardiopulmonary ag has initiated a capa process (capa (b)(4)) to address the appropriate corrective and preventive action.The most probable root-cause will be tracked through capa (b)(4), as well as continuous monitoring of upcoming complaints for trends.Add'l info: the product mentioned is a tubing set and the included affected component has the contributing design function of the quadrox-id which is registered under 510(k): k101153.

Event Description

It was reported that blood leakage of less than 10 cc was observed at the gas outlet port of the device.No reported pt effect.

• Brand Name: BE-FLS 2050#PERMANENT LIFE SUPPORT SET
• Type of Device: TUBING SET
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 14755891
• MDR Text Key: 295250101
• Report Number: 8010762-2014-01334
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2016
• Device Catalogue Number: 70102.7818
• Device Lot Number: 70099743
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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