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 Detachment Of Device Component (1104); Fluid/Blood Leak (1250)

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

Event Date 11/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was requested but not yet received.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the customer: "during the procedure the protective cap that covers the hole in the spike connected to the cardioplegia (article (b)(4)) fall apart generating a leakage in the line." (b)(4).

Manufacturer Narrative

(b)(4).The device is not available for manufacturers laboratory investigation.Device history record of the lot has been investigated and no abnormality was found.A review of similar complaints was performed.A similar complaint investigation was found with the following results: samples with the same failure were forwarded to the supplier.Based on the information from the supplier,the failure could have occurred during transport, storage or sterilization of the component, which made the retaining force of the filter weaker.Our storage and sterilization conditions are automated and monitored, so it could not have an influence.As far as transportation is concerned,we monitor the trucks with data-loggers during the hottest season.If there was an influence on transportation, all of the pieces would be affected.The most probable root cause is material failure.There is no assembly process of the cap in our production.Based on the information provided by the supplier, the assembly process of the claimed cap is outsourced.An internal clinical assessment has been performed based on the received complaint report.It seems that this incident is not user error but rather a failure of the spike.As corrective action, a supplier complaint has been opened to the supplier of the spike.Also,the investigation results were evaluated and we will continue monitoring the trend in our production.The document related to this process was revised and control points were added.The data is also being handled through trending and applicable investigation process.If a trend occurs,it will be escalated to qa management for review and determination if further investigation is necessary.

Event Description

(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: 6198202
• MDR Text Key: 63547852
• Report Number: 8010762-2016-00730
• 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,Followup
• Report Date: 06/23/2017

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 12/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/23/2017
• 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: Initial
• Patient Sequence Number: 1