MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET W/SOFTLINE COATING; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number BO- H 46700

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/11/2016

Event Type  malfunction  

Manufacturer Narrative

The product is not available for manufacturers laboratory investigation.A review for similar complaints was performed.A similar complaint investigation was found with the following results: the product was investigated in the laboratory of the manufacturer.The blue caps and the fitting on the spikes (2 each) were checked for their dimensions; no abnormalities were found the dimensions were within tolerance.During functional evaluation it was possible to remove the blue caps easily from the spikes fitting by hand.The complaint data and investigation results were evaluated by the supplier maquet cardiopulmonary (b)(4).A dhr review of the lot affected was performed with no abnormalities found.No scrap record for the related material was found.The supplier confirmed during the investigation of the complaint sample that the cap was very easily removable.The most probable cause of the failure was determined as material failure.No big measurement difference was found.As a corrective action, a supplier complaint has been opened to the sub supplier of the cap.The sub supplier stated that the assembly process of the cap is outsourced.It was requested that the sub supplier implements qualification, training, process and in-process / final controls.Also the operators of maquet (b)(4) have been informed about the complaint.Based on the above mentioned former investigation results the reported problem could be confirmed.This data will be handled through a designated maquet trending process.

Event Description

"the perfusionists realised that the protective cap of the hole in the spike connected to the cardioplegia article 05008 had fallen apart and there was a leakage in the line." (b)(4).

• Brand Name: HLM TUBING SET W/SOFTLINE COATING
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 6083389
• MDR Text Key: 59565112
• Report Number: 8010762-2016-00661
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K090533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/11/2016

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: 12/22/2017
• Device Model Number: BO- H 46700
• Device Catalogue Number: 701051993
• Device Lot Number: 92179785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 11/07/2016
• Date Device Manufactured: 12/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1