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

Model Number BEQ-HMOD30000-USA

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2017

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).The device was requested but not yet received.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the customer: during scheduled shift inspection of the oxygenator membrane, it was noted that a potential clot was starting to form on the right-hand corner of the oxygenator face and along the top edge after day 1 of support.Upon closer inspection, it was noted what appeared to be leakage into the potting material into the periphery of the oxygenator.Change out was not required, leakage appeared to be internal per (b)(6) and contained to a small area.No changes in trans-membrane pressure or oxygenator function was noted.Patient was on vv ecls for 3 days and weaned without incident.(b)(4).

Manufacturer Narrative

The product was investigated in the manufacturer laboratory with the following result.A quadrox-id pediatric was sent back.Clots can be confirmed on the blood inlet and the blood outlet side.Oxygenator cleaned several times with sodium hypochlorite.Leak test performed.A leak at the venting membrane after approx.2 sec.Venting membrane closed, no further leaks could be detected.Colored oxygenator.The pur casting was compared with a model part pediatric.Both patterns look identical.The pur was not exactly shed in the corners.All fibers were cast around.No leakage was detected.No further abnormalities noted.Clots can be confirmed.A leak at the de-airing membrane (a new complaint will be opened to track and trend this observation) after approx.2 sec.Vent membrane closed, no further leaks could be detected.The pur casting was compared to a model part pediatric.The pur was not exactly shed in the corners.All fibers were cast.No leakage was detected.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.No corrective action is needed.

Event Description

Internal reference: (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: 7004017
• MDR Text Key: 92511931
• Report Number: 8010762-2017-00356
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K100278
• 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: 01/15/2018

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 Expiration Date: 10/17/2018
• Device Model Number: BEQ-HMOD30000-USA
• Device Catalogue Number: 701050330
• Device Lot Number: 70113995
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2017
• Initial Date FDA Received: 11/06/2017
• Supplement Dates Manufacturer Received: 11/03/2017
• Supplement Dates FDA Received: 01/15/2018
• 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