MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG OXYGENATOR,CARDIOPULMONARY BYPASS; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BO-VKMO 51000

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 11/27/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the hospital: "during the procedure, the customer noticed blood was leaking from the de-airing port on the blood inlet side.The slight blood leakage continued through the procedure.According to the customer, the blood leakage increased in proportion to the flow and the pressure.The customer kept using the device till the end of the procedure while keeping the level of flow and pressure low." (b)(4).

Event Description

(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, 45 barbour pond drive, wayne, nj 07470.Contact person- (b)(4).A quadrox-i small adult was sent back.The product was contaminated.A leak test performed.A leak at the venting membrane can be confirmed.The adhesive for the venting membrane was not evenly distributed.In order to better recognize the error, the vent membrane from the outside and the adhesive area were stained with methylene blue.The membrane itself is tight,only the bond is faulty.There were no further abnormalities.Dhr review result: affected product:basic lot 70120442 and packaging lot 70120442(serial number (b)(4)).The avz from vmv785 to vmv799(dms# (b)(4))was reviewed.There were no references found,which are indicating a nonconformance of the product in question.Sap trend search was performed(product groups:11000,56000,23100,31000 and failure codes:0102 leak at the inlet connector and 0426 cracked luer lock inlet connector) which came to following results:7 additional complaints were recorded which appears reported issues are the same since the last 12 months.Based on the sales figures of the last 12 months following occurrence rate has been calculated: (b)(4),which is below (b)(4).Due to this information no systemic issue could be determined.The manufacturer`s review of the steps in production indicated that a related inspections are conducted during manufacturing.The information obtained so far in this investigation would confirm that the device met its specification at the time of manufacturing and therefore all damages found on the product are due to excessive or inadequate external physical force that was exerted on the product after the release.The exact root-cause which led to the described failure could not be identified.The data is being handled through a designated maquet trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

• Brand Name: OXYGENATOR,CARDIOPULMONARY BYPASS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 8125106
• MDR Text Key: 129336248
• Report Number: 8010762-2018-00312
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K090689
• 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: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2020
• Device Model Number: BO-VKMO 51000
• Device Catalogue Number: 701068197
• Device Lot Number: 92243940
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 01/15/2019
• Supplement Dates FDA Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other