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

Model Number BEQ-HMOD30000-USA#Q

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).(b)(6).The device has been requested but not yet received.

Event Description

Blood was leaking from arterial inlet connector after 90 minutes of being in use on patient.No harm reported.A new oxygenator was used.(b)(4).

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).Rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).Importer- maquet medical systems usa (b)(4).Contact person- (b)(6).Maquet cardiopulmonary gmbh requested the product for investigation in the laboratory of the manufacturer.The returned oxygenator was investigated in the laboratory of the manufacturer.A quadrox-id pediatric with bioline coating was sent back.The sample was contaminated.Purified with sodium hypochlorite.Visual inspection performed.A crack that goes beyond the splice of the blood inlet connector was detected and leads to the reported leak.No further abnormalities could be detected.Thus the failure could be confirmed.When and what caused the discovered crack is unclear at this time.The time when the crack originated can not be determined.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.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.

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
• MDR Report Key: 7845599
• MDR Text Key: 119508785
• Report Number: 8010762-2018-00252
• 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
• Type of Report: Initial,Followup
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2019
• Device Model Number: BEQ-HMOD30000-USA#Q
• Device Catalogue Number: 701050330
• Device Lot Number: 70118469
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention