MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING SETS; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number BEQ-HQV 48707

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2019

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Quest one way valves leaking blood while in use.Complaint: (b)(4).

Manufacturer Narrative

Maquet cardiopulmonary gmbh performed technical investigation based on similar complaint.There is a similar complaint which was same malfunction reported from same lot # of suction valve.Similar product, showing a similar malfunction has been already investigated under complaint #(b)(4): during visual inspection of the vacuum valve, blood was detected on the outlet side between the connector and the tube connection.The valve was tested with water at pressure approximately 70.0 mbar (52.5 mmhg).A leak was detected on the upper (umbrella) side of the valve.Based on this failure could be confirmed.The vacuum valve is a purchased part from quest medical, inc.There is no any functional test during production.There is direction controls per fb-005 v13 tubing set control form and per device history record review results, it was performed by operators.No similar nonconformity record was found for material 70102.5887 in last 24 months.No similar supplier corrective action record was found for material 70102.5887 in last 24 months.Device history record for complaint (b)(4) and lots 92262933, 92244769 were reviewed.There are no evidences indicating a non conformance or deviations of the product in question during the manufacturing and final release of this specific lot.Trend search was performed for component suction valve and failure leakage and 5 additional complaints were recorded within last 12 months.10 sets from each lot were complained in this complaint record.As the failure is already known to maquet cardiopulmonary a capa process was initiated in order to determine the root cause and initiate further actions to determine corrective measures for the failure.All further actions in regard to the reported failure will be performed within capa #259464.This complaint is being monitored as part of the complaint data trending of maquet cardiopulmonary gmbh and further investigations and measures will be conducted in case of adverse trending.

Event Description

Complaint #(b)(4).

• Brand Name: TUBING SETS
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9317073
• MDR Text Key: 197775278
• Report Number: 8010762-2019-00362
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K053025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2022
• Device Model Number: BEQ-HQV 48707
• Device Catalogue Number: 70106.2275
• Device Lot Number: 92262933, 92244769
• Date Manufacturer Received: 12/17/2019
• Patient Sequence Number: 1