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

Model Number OTHER TUBING SETS & COMPONENTS

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the customer, the leak was detected at y connector during the operation.Complaint: (b)(4).

Event Description

(b)(4).

Manufacturer Narrative

The affected product (be-00365 1/4 *1/4*1/4 ll) was requested from the customer for the sample investigation.However, according to the maquet cardiopulmonary laboratory, there was no y connector in the package received.Since the affected product could not be received , no sample investigation could be performed.According to the received information from the ssu, the leakage occurred at the luer part of the connector.Maquet cardiopulmonary gmbh is aware of similar complaints from this product.Similar product, showing a similar malfunction, has been investigated in #703007102; according to this investigation, ''two 1/2 x 3/8 x 1/2 y connectors with luer lock (part no.70000.0273) were returned.1st pattern.Y connector with temperature sensor on the luer lock.Luer lock has several cracks.2nd pattern.Y-connector with a foreign screw cap on the luer lock.Luer lock has several cracks on.Based on this failure could be confirmed.''.Thereby a leakage from y-connector could be confirmed.The reported failure was identified as part of the current risk management file (dms #1906296 v.19).Mitigations for this specific failure are in place as per instruction for use warnings and design specifications and also in manufacturing processes in order to reduce of similar failures.Trend search was performed and no systemic issue could be found.Device history record for lot 92275040 was 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.The device was manufactured in compliance with defined production steps and specifications.Appropriate manufacturing documentation and production step controls were in place.Therefore no manufacturing problem was detected.Getinge cardiopulmonary antalya also investigated the issue.During manufacturing there is 100% visual controls of connectors for cracks and damages according to basic operation procedure 9201212 rev.0.It could be confirmed 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.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.

• 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: 10107979
• MDR Text Key: 193425307
• Report Number: 8010762-2020-00185
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2020
• Device Model Number: OTHER TUBING SETS & COMPONENTS
• Device Catalogue Number: 70103.3326
• Device Lot Number: 92275040
• Date Manufacturer Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1