MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG PERMANENT LIFE SUPPORT SET; NONE

Model Number 70102.7818

Device Problems Crack (1135); Fracture (1260); Material Integrity Problem (2978)

Patient Problem Not Applicable (3189)

Event Date 05/20/2015

Event Type  malfunction  

Event Description

During the investigation of the product component in question, initiated from customer complaint (b)(4) / mfr report # 8010762-2015-00257, an additional failure was found.Cracks on the blood outlet connector were visible.Ref.# (b)(4) customer ref.: n/a.

Manufacturer Narrative

Maquet cardiopulmonary performed a visual inspection on the product sample that was returned for the investigation of complaint (b)(4) / mfr report # 8010762-2015-00257.During this inspection, cracks were seen on the blood outlet connector of the component oxygenator.No evidence was provided that this failure was noticed within the initial complaint report.The manufacturers review of the quality control process indicated that a 100% functional inspection for leakage is conducted during manufacturing.The info obtained so far in this investigation would confirm that the device met its specification at the time of manufacturing and therefore all damages found on the product are due to excessive or inadequate external physical force that was exerted on the product after the release.The exact root-cause which led to the described failure could not be identified.The data is being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.Additional info: the product mentioned, is not distributed to the us, but the product with contributing design function to the affected component (quadrox-i) is registered under 510 (k) : k101153.

• Brand Name: PERMANENT LIFE SUPPORT SET
• Type of Device: NONE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt ; GM ; 2229321132
• MDR Report Key: 4861668
• MDR Text Key: 5812700
• Report Number: 8010762-2015-00734
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70102.7818
• Device Catalogue Number: BE-PLS 2050
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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