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

Model Number 01931110#QUADROX-I PÄDIATRIC +FILTERED MICRO.SOFT.

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported by sales unit on (b)(6) 2019 reported two batches regarding complaint # (b)(4) were found during two different cases.Therefore second emdr has been created.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

The user ((b)(4)) complains 2 pieces hmo 31000.Lot: 70122866.Lot: 70122025.Following the description of the user: at the arterial outlet connector there is a fine hairline tear in both oxygenators! this became visible after priming the system, which also could not be sealed.The oxy was then exchanged and thus no danger to the patient.Cormed complaint: (b)(4).Complaint: (b)(4).

Manufacturer Narrative

Maquet cardiopulmonary gmbh was requested the product back for investigation in the laboratory of manufacturer.Visual inspection and leak test per local procedure lv 201 were performed.In both products, hairline cracks were detected at the blood outlet connector and the luer lock connector on the outlet side.Based on this, failures could be confirmed.Trend search was performed.7 additional complaints were recorded in the last 12 months.The occurrence rate regarding this complaint is below the acceptance criteria.Thus, no remedial action required.Device history record for lot #70122866 was reviewed.There were no references found, which are indicating a nonconformance of the product in question.The reported failure was identified as part of the current risk management file (dms#(b)(4)).Mitigations for this specific failure are in place as per instruction for use warnings and design specifications.The manufacturer`s review of the control form in production indicated that a 100% visual inspection for deformation is 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.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: OXYGENATOR, CARDIOPULMONARY BYPASS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9433502
• MDR Text Key: 204926332
• Report Number: 8010762-2019-00385
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K132829
• 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: 01/30/2020

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: No Information
• Device Model Number: 01931110#QUADROX-I PÄDIATRIC +FILTERED MICRO.SOFT.
• Device Catalogue Number: 701048493
• Device Lot Number: 70122866
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 01/28/2020
• Supplement Dates FDA Received: 01/30/2020
• Patient Sequence Number: 1