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

Model Number BE-VKMO 70000

Device Problems Leak/Splash (1354); Component Missing (2306)

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

Event Date 03/15/2018

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: "the oxys are from the (b)(4) be-vkmo 70000 # squadr-i hmo70000 + vhk71000 with lot 92221252, which were supplied with order (b)(4).The luer lock at the oxy blood outlet had a leak, half of the thread is missing / is smooth.4 oxys were affected to date.The perfusion was nevertheless performed.There was no patient risk." (b)(4).

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary(b)(4).Rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).Importer- maquet medical systems usa (b)(4).Contact person- (b)(6).The product is not available for investigation in the laboratory of manufacturer.We have received a picture related to the complaint.Device history record could not be reviewed.Since, serial number of oxygenator is unknown.Sap trend search was performed (failure code 0105 leak at the oxy blood outlet and similar production group) which came to following results:8 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: 0%, which is below 1%.Due to this information no systemic issue could be determined.Related to the complaint, we requested assistance from lce.According to advisor¿s comment, it is not possible to come to a final conclusion only by regarding the complaint picture.Also, according to the failure description, it says ¿half of the thread is missing / is smooth¿.This is correct and the regular design of the luerlock.All oxygenators using this blood connector only have a thread on one half of it.This cannot be the reason for the leakage because this is how it should look like.Therefore, it would be very important to have a leaking sample for investigation , it is not available.The sample was not returned to us for investigation and the serial number of oxygenator is unknown.The provided information with the complaint wasn¿t enough to determine the exact root cause.Based on this complaint could not be confirmed.The data is being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

Event Description

Ref.: #(b)(4).

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7365556
• MDR Text Key: 103548300
• Report Number: 8010762-2018-00108
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K082117
• 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: 07/10/2018

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: 04/14/2019
• Device Model Number: BE-VKMO 70000
• Device Catalogue Number: 701067956
• Device Lot Number: 92221252
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/15/2018
• Initial Date FDA Received: 03/23/2018
• Supplement Dates Manufacturer Received: 07/09/2018
• Supplement Dates FDA Received: 07/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1