MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET W/ BIOLENE COATING

Model Number BE-HLS 7050

Device Problems Loss of or Failure to Bond (1068); Crack (1135); Fluid/Blood Leak (1250); Fracture (1260); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 07/17/2015

Event Type  malfunction  

Manufacturer Narrative

The product was investigated in the laboratory of the mfr.During visual inspection of the blood inlet connector's gluing connection hair-line cracks in the plastic were found.A tightness test was performed and a leakage of this connection was confirmed.By slightly moving the blood inlet connector after it's safety fixture was unfixed from the housing (loosening the screws) it was completely detached from the module.This additional complaint was opened in order to cover this failure.A device history record review was performed by a designated maquet member with no abnormalities found.The review of the quality control process indicated that the oxygenator was tested for its tightness during production.This should be adequate to detect products that do not meet the performance specs prior to release for final packaging and sterilization.Furthermore history records of the glue used for the connector were reviewed with no abnormalities found.The most probably cause of the failure detected is unk.The detected failure was not reported by the customer.This failure was determined to be the first of its kind and is being handled through a designated maquet trending process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further action will be completed at this time.

Event Description

During investigation of an complaint in the laboratory of the mfr by visual inspection an additional malfunction was found.At the blood inlet connector's gluing connection hair-line cracks in the plastic were found.A tightness test was performed and a leakage of this connection was confirmed.By slightly moving the blood inlet connector the glued connection of the blood inlet connector get loosened.The connector was detached from the module.This additional complaint was opened in order to cover this failure.(b)(4).

• Brand Name: HLM TUBING SET W/ BIOLENE COATING
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strabe 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4988435
• MDR Text Key: 22579556
• Report Number: 8010762-2015-00874
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Not Applicable
• Report Date: 07/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: BE-HLS 7050
• Device Catalogue Number: 70104.7753
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/23/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/17/2015
• 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