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

Model Number BEQ-HMOD70000-USA

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 12/14/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the customer: the customer reported the following in regards to blood leakage from the diacon connector: this was placed on a patient on (b)(6) at approximately 0930.From my understanding the small leak occurred right away, and again from the arterial side access port centered in the oxygenator.It has since clotted.(b)(4).

Manufacturer Narrative

The product was investigated in the laboratory of the manufacturer.During a tightness test a slight leakage at the dialysis lock and valve could be confirmed after one hour duration.Thus the reported failure could be confirmed.Dhr review result: affected product: basic lot 70118251 and packaging lot 70118230 (serial number ape (b)(4)).The avz from (b)(4) was reviewed on (b)(6) 2018.There were no references found, which are indicating a nonconformance of the product in question.Since the reported failure did not contribute to a death or serious injury and no systemic issue could be determined no corrective action is needed 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): 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: 7171712
• MDR Text Key: 96727319
• Report Number: 8010762-2018-00004
• 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: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2019
• Device Model Number: BEQ-HMOD70000-USA
• Device Catalogue Number: 701053824
• Device Lot Number: 70118230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2018
• Date Device Manufactured: 07/01/2017
• 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