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

Model Number BO-VHK 71000-J

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

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

Event Date 12/05/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the hospital: "the priming was performed, and was standing-by for the cpb start.Then, water drop was found on the floor under the circuit.They studied the circuit assembly, tightened the each connection, confirmed everything was okay, and then, started the extracorporeal circulation.Before cpb reached to 100%, blood drop was noted on the floor; it was leaking from the one-way valve of the sampling manifold." (b)(4).

Event Description

Ref.: #(b)(4).Customer ref.: #(b)(4).

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.Importer- maquet medical systems usa (b)(4).Contact person- (b)(6).The product was received for investigation in the laboratory of manufacturer.During visual control a crack was found on the outlet side of the one-way valve.When leak test was performed, the valve leaked from that part.Sap trend search was performed (material 70106.6420, failure code 0128 manifold line) which came to following results: 0 additional complaint was recorded which appears reported issues are the same since the last 12 months.(b)(4).Due to this information no systemic issue could be determined.Maquet cardiopulmonary gmbh is aware of totally 20 similar incidents recorded with different material numbers and failure codes in last 12 months.Based upon similar incidents supplier complaint was already initiated.The most probable cause of the failure is found as material failure.Device history record was reviewed.There were no references found which are indicating a non-conformance of the product in question.The reported failure did not contribute to a death or serious injury.In addition it cannot be concluded that this is a systemic error.As a corrective action, supplier complaint (751001063) was already initiated regarding similar incidents.This complaint was also added to this scar.All further actions will be followed by scar.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.Due to this no further investigation initiations will be completed at this time.

• Brand Name: VENOUS HARDSHELL CARDIOTOMY RESERVOIRS
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7171650
• MDR Text Key: 96833134
• Report Number: 8010762-2018-00002
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• PMA/PMN Number: K090534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/16/2018

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: 10/07/2018
• Device Model Number: BO-VHK 71000-J
• Device Catalogue Number: 701066420
• Device Lot Number: 92213844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 01/08/2018
• Supplement Dates Manufacturer Received: 07/10/2018
• Supplement Dates FDA Received: 07/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1