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

Model Number VKMO 10000#

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombus (2101)

Event Date 10/13/2015

Event Type  malfunction  

Manufacturer Narrative

November 09, 2015 10:41 am (gmt-5:00) added by (b)(6): (b)(4).A supplemental medwatch will be submitted when additional information becomes available.

Event Description

Customer reported that: "there was clotting on the screen filters of the reservoir during the operation." (b)(4).

Manufacturer Narrative

(b)(4).Investigation is not possible: neither sample is available nor pictures of the failure.Thus the failure could not be confirmed.There are many reasons for clotting: according to clinical advisor; during an operation, clotting occurs on almost every foreign surface of cpb-components if no heparin or an alternative anticoagulation is given.If clotting occurs during cpb the balance between anticoagulation and coagulation system is disturbed.Unfortunately, it is not uniformly possible to predict how patients react to a certain dose of heparin.There.Several other than flow and no blood flow, long cpb times, onset of heparin-induced thrombocytopenia, disseminated intravascular coagulation (dic), sepsis or preexisting conditions that impact on coagulation system, organ injury, e.G.Lung, where certain substances are released.Another reason could be that the heparin dosage was too low despite a good act.It could be possible that acts at the lower end of sufficient anticoagulation and rather low blood flow.Clotting is a known phenomenon to maquet cardiopulmonary and has been thoroughly investigated in previous complaints.The cause of this failure was determined to not be attributed to a device related malfunction.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: NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MICHAEL CAMPBELL; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437
• MDR Report Key: 5212185
• MDR Text Key: 31081390
• Report Number: 8010762-2015-01151
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K102919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2015

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: 11/01/2016
• Device Model Number: VKMO 10000#
• Device Catalogue Number: 70106.6457
• Device Lot Number: 92158445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2015
• Initial Date FDA Received: 11/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/04/2016
• Date Device Manufactured: 11/01/2014
• 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