MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG VKMO 30000 # QUADROX - I PAD. MIT RESERVOIR; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Model Number 70105.0111

Device Problems Complete Blockage (1094); Failure to Prime (1492)

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

Event Date 06/02/2015

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned yet for evaluation.Additional information: the product mentioned is a tubing set with reservoir and the included affected component has the contributing design function of the reservoir which is registered under 510 (k): k102919.A supplemental medwatch will be submitted after receipt of new information.

Event Description

According to the customer: "oxygenator and circuit was primed with clear prime initially and circulated then circuit was primed with blood.Reservoir was clogged and was not functional.Blood was infused using trans fusion set.Treatment was delayed by 30 min." it took place during priming, no known consequences to the patient.(b)(4).

Manufacturer Narrative

The set was not available for investigation.The customer had scrapped it and replaced it.Photographs are available.An investigation by maquet (b)(4) based on the available information and the photographs concluded that the root cause of the problem could not be established as there was insufficient information concerning this complaint.A dhr review of lot 92152104 and incoming inspection reports for the filters for the reservoir in question were checked and no abnormalities were found.Additional information regarding the case was requested three times.Some answers were available on 2015-12-22 to the questions sent out, but these were not sufficient to help determine root cause.To try to establish root cause, a clinical evaluation noted that the function of unit could be impaired during operation if it was not used as intended, however no further information related to actual use is available.A review for similar complaints has been performed and only one 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 management for review and determination if further investigation is necessary.Due to this no further action will be completed at this time.

Event Description

(b)(4).

• Brand Name: VKMO 30000 # QUADROX - I PAD. MIT RESERVOIR
• 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: michael campbell ; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; GM 76437 ; 4972229321
• MDR Report Key: 4927934
• MDR Text Key: 22448617
• Report Number: 8010762-2015-00823
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K102919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2016
• Device Model Number: 70105.0111
• Device Lot Number: 92152104
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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