MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG PEDIATRIC VENOUS HARDSHELL; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Model Number VKMO 11000

Device Problem Complete Blockage (1094)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product was requested to return for manufacturers laboratory investigation but it was scrapped.Also, there was no information about the lot number of the set and no picture related to the failure.Therefore, dhr review could not be performed.The root cause of the problem could not be established as there was insufficient information concerning this complaint.Additional information regarding the case was requested three times.A review for similar complaints has been performed and a similar incident from the same institution was found.Based on this, a confirmation of the failure based on previous complaints is not possible, and there is no systemic issue indicated.This data will be handled through a designated maquet trending process.If a trend occurs, it will be escalated to quality assurance managemement for review and determination if further investigation is necessary.Due to this no further action will be completed at this time.

Event Description

According to the customer: "interior segment of reservoir seemed to have positive pressure despite the application of vacuum.A few cc's of blood vented.Concern they reservoir filter may be clogging.It was mentioned this happened 3 times total.This is the 2nd of those 3 complaints.Device was not retained." (b)(4).

• Brand Name: PEDIATRIC VENOUS HARDSHELL
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• 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: 6002819
• MDR Text Key: 57273021
• Report Number: 8010762-2016-00613
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• PMA/PMN Number: K102919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/20/2016

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 Model Number: VKMO 11000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2016
• Initial Date FDA Received: 10/06/2016
• 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