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

Model Number QUADROX-I ADULT (VKMO) W/ FILTER

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/04/2019

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.Importer- (b)(4).

Event Description

Bleed cock at the inlet of the integrated filter drips.Complaint no: (b)(4).

Manufacturer Narrative

Maquet cardiopulmonary gmbh was not requested the product back for investigation since the issue is known.Maquet cardiopulmonary ag is aware of similar complaints from this product.Similar product, showing a similar malfunction, has been investigated in (b)(4).Under scope of the complaint (b)(4) ; maquet cardiopulmonary gmbh was received the product back for investigation.A quadrox-i was returned.The product was contaminated.Visual inspection was performed.A long crack on the luer lock near the vent cock was detected, so, it was decided that the leak test was not necessary.No other abnormalities could be detected.The failure was confirmed by the laboratory.The manufacturer`s review of the control form in production indicated that a 100% visual inspection 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.

Event Description

Complaint: #(b)(4).

• Brand Name: OXYGENATORS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 8850353
• MDR Text Key: 152946020
• Report Number: 8010762-2019-00231
• 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: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: QUADROX-I ADULT (VKMO) W/ FILTER
• Device Catalogue Number: UNKNOWN
• Date Manufacturer Received: 09/12/2019
• Patient Sequence Number: 1