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

Model Number BEQ-HMOD 70000

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 09/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been requested but not yet received.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the customer- just put a child on ecmo and when they ere putting together and clearing priming circuit it was noted that there was something in the oxygenator.They did know what it was but it is contaminated with something.Customer stated a foreign body was noticed in the oxygenator and it looked like a "booger" they pulled the oxygenator to exchange it.(b)(4).

Manufacturer Narrative

The product was investigated in the manufacturer laboratory with the following result.During the visual inspection, clots were detected and documented on the blood inlet side.No other foreign bodies or abnormalities detected.The "booger" are clots.Purified with sodium hypochlorite.No other foreign bodies or abnormalities detected.Failure could be confirmed.Conclusion: on visual inspection were on the blood inlet side clots determined and documented.No other foreign bodies or abnormalities detected.The "booger" are clots.Thus the failure could be confirmed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.

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): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 6872730
• MDR Text Key: 87349363
• Report Number: 8010762-2017-00300
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2018

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 Model Number: BEQ-HMOD 70000
• Device Catalogue Number: 701053824
• Device Lot Number: 70110532
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2017
• Initial Date FDA Received: 09/18/2017
• Supplement Dates Manufacturer Received: 09/10/2017
• Supplement Dates FDA Received: 01/22/2018
• Date Device Manufactured: 04/01/2016
• 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