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

Model Number VKMO 11000

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the customer: "during use, the user indicated that there was positive pressure on the interior area of the reservoir.Supposedly an attached bag slightly inflated.Supposedly additional vacuum deflated the bag there clearly is a question about the pressure relief valve." (b)(4).

Manufacturer Narrative

(b)(4).The item was requested to be returned to the factory for investigation.However, the sample was supposedly returned along with another sample under a different complaint number, and that complaint number is not known.It has not been possible to locate, and therefore, investigate and evaluate the product.As such, the reported issue cannot be confirmed.Positive pressure within the reservoir could be caused by a number of different factors (for example, blockage of the cardiotomy filter or the defoaming unit), but without directly investigating the item in question, it is not possible to establish a clear root cause for the reported issue.It was not possible to perform a dhr review for this complaint, as the product/part details such as the material number and lot number are not known.Based on the investigation and trending for the issue, a systemic issue is not indicated.Due to lack of the product for identification and evaluation, no further investigation is currently possible, and the complaint will be closed.Should the sample for this complaint be located, an investigation will be carried out and the complaint reopened and updated as appropriate.

Event Description

(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: 6076734
• MDR Text Key: 59415246
• Report Number: 8010762-2016-00655
• 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,Followup
• Report Date: 09/08/2017

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 Model Number: VKMO 11000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2016
• Initial Date FDA Received: 11/03/2016
• Supplement Dates Manufacturer Received: 10/06/2016
• Supplement Dates FDA Received: 09/08/2017
• 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