MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING SETS; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Model Number H 16105

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

"during cardiopulmonary bypass surgery leakage from arterial filter quart lot # 70129137, which is a part of tubing set h 16105 was detected." complaint: (b)(4).

Event Description

(b)(4).

Manufacturer Narrative

Maquet cardiopulmonary gmbh requested the product back for investigation on 2019-11-18.Information was received on 2019-12-06 that the product was scrapped by customer.Therefore no technical investigation could be performed on actual product.A video was received regarding failure.In this video, it could be seen that the priming solution is leaking from the housing of the filter.Maquet cardiopulmonary gmbh is aware of similar complaint from this product.Similar product, showing a similar malfunction has been investigated in: #703007087: 70000.0175/ 00175#quart, halbfertigteil was sent back.The product was tested with air (approx.0,1 bar pressure) under water to detect the leakages.Leakage was detected at the bonding between the housing and the cover.Based on the information above, failure could be confirmed.Since actual defective device is not available for investigation, the cause of the failure could not be identified.The cause of the failure is unknown.A trend search was performed for component quart, failure leakage and 5 additional complaints were recorded within the last 12 months.(b)(4).In addition, device history records for complaint (b)(4) and lots 70129137 & 92271362 have been 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 reported failure was identified as part of the current risk management file ((b)(4)).Mitigations for this specific failure are in place as per instruction for use, design specifications and in-process controls in order to reduce of similar failures during the manufacturing process.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: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9346550
• MDR Text Key: 189881034
• Report Number: 8010762-2019-00367
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• PMA/PMN Number: K001787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2021
• Device Model Number: H 16105
• Device Catalogue Number: 70100.3936
• Device Lot Number: 92271362
• Date Manufacturer Received: 12/10/2019
• Patient Sequence Number: 1