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

Model Number VKMO 31000

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 11/13/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product was disposed at the hospital, therefore no manufacturer laboratory investigation was possible.A review of similar complaints was performed.A similar complaint with a previous product investigation was found.The investigation results of the similar complaint were as follows: a dhr review confirmed that the oxygenator was tight during production.During manufacturer laboratory investigation was confirmed that the leakage was caused by a crack.As the customer stated in the complaint report that a crack was detected at the fitting all way down, this would be the most probable cause for the leakage.Based on this and on the previous investigation mentioned above the reported failure could be confirmed.Our review of the quality control process indicated that a 100% functional inspection for leakage is conducted during manufacturing.This should be adequate to detect products that do not meet performance specifications prior to release for final packaging and sterilization.This data will be handled through a designated maquet trending process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further action will be completed at this time.The product was disposed at the hospital, therefore no manufacturer laboratory investigation was possible.A review of similar complaints was performed.A similar complaint with a previous product investigation was found.The investigation results of the similar complaint were as follows: a dhr review confirmed that the oxygenator was tight during production.During manufacturer laboratory investigation was confirmed that the leakage was caused by a crack.As the customer stated in the complaint report that a crack was detected at the fitting all way down, this would be the most probable cause for the leakage.Based on this and on the previous investigation mentioned above the reported failure could be confirmed.Our review of the quality control process indicated that a 100% functional inspection for leakage is conducted during manufacturing.This should be adequate to detect products that do not meet performance specifications prior to release for final packaging and sterilization.This data will be handled through a designated maquet trending process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further action will be completed at this time.

Event Description

According to the customer: "the customer experienced a leak from the luer port of the oxygenator where the de-airing tap is located.Upon examination after changing out, i noted that the fitting was cracked all the way down the port.The product was disposed" (b)(4).

Manufacturer Narrative

The product was received at the manufacturer without any previous notice that was available for investigation.It was originally reported the device was disposed of.The product was sent to the manufacturer laboratory for investigation.A visual inspection and a tightness test determined that a crack at the luer lock of the de-airing stopcock was causing the leakage.As the customer stated in the complaint report, a crack was detected at the fitting all way down, this would be the most probable cause for the leakage.Based on this, the reported failure could be confirmed.Our review of the quality control process indicated that a 100% functional inspection for leakage is conducted during manufacturing.This should be adequate to detect products that do not meet performance specifications prior to release for final packaging and sterilization.It is most probable, the crack was caused by inner material stress or excessive force.This data will be handled through a designated maquet trending process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further action will be completed at this time.

Event Description

(b)(4).

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MICHAEL CAMPBELL; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437
• MDR Report Key: 5274856
• MDR Text Key: 33321946
• Report Number: 8010762-2015-01224
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2015

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: Health Professional
• Device Expiration Date: 06/01/2016
• Device Model Number: VKMO 31000
• Device Catalogue Number: 70104.9185
• Device Lot Number: 92135383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1