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

Model Number BO-HQV 62900

Device Problems Cut In Material (2454); Material Integrity Problem (2978)

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

Event Date 04/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary (b)(4) requested the product back for investigation.Investigation is still pending.A supplemental medwatch will be submitted as soon as further information becomes available.

Event Description

Customer reported that there was a deep cut in the venous line.There was no consequence for the patient.Customer reported that the deep cut was not noticed during priming as obviously pressure was not that high and this was noticed when the tubing was bent.(b)(4).

Manufacturer Narrative

The product was returned to the maquet for investigation and was visually inspected in the maquet complaints laboratory.Two cuts were found at the connecting end of the tubing.One was lengthwise, and the other across the tubing near the connector.A device history record of the affected lot has been investigated and no abnormality was found.Also, there is no failure record for the tube cutting machine.Although the failure occurred during operation, the customer should have detected the issue during priming of the set.The investigation results and the available information are inconclusive in establishing a clear root cause.External physical effects are considered to be the most likely cause for the reported incident, and this could include a handling issue during assembly.As a corrective/preventive action, the operators were retrained in the 100% visual inspection procedure.Also, any marks or scratches found on the tubing are referred to the supplier to evaluate.An improved cutting tool has also been introduced ((b)(4)2015).The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Based on the investigation results, no further investigation or action is warranted at this time and the complaint will be closed.This is the final report.

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: 5632598
• MDR Text Key: 45035946
• Report Number: 8010762-2016-00312
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 04/12/2016

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: 12/01/2017
• Device Model Number: BO-HQV 62900
• Device Catalogue Number: 70103.5710
• Device Lot Number: 92175385
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2016
• Initial Date FDA Received: 05/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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