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

Model Number HMO 71000 J

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 10/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product was requested to return for manufacturer's laboratory investigation and was not yet received by the manufacturer.The investigation is still pending.A supplemental medwatch will be submitted when further information becomes available.

Event Description

According to the customer: 1 hour.After the extracorporeal circulation started, blood leakage from the dialysis lock valve was noted.The customer taped the leakage point and continued the procedure.They stayed on the same device as it was a slight leakage and finished the surgery without no effects on the patient.The pressure during pumping was 250mmhg.-no adverse effects on the patient.-the incident occurred during the patient use.(b)(4).

Manufacturer Narrative

The product was investigated at the laboratory of the manufacturer.A tightness test was performed.A slight leakage was confirmed hereby.No further abnormalities were detected.Thus the reported failure could be confirmed.Mcp decided to initiate a capa (corrective and preventive action) process in order to determine the root cause and initiate further steps.All further steps will be performed out of the capa (b)(4) process.Most probable root cause identified: the injection molding tool for component "filterlid" (70103.0908) has a separation which is directly placed on the sealing groove.The edges of this separation show wear.The injection molding tool process for component "filterlid" (70103.0908) is not validated.Corrective / preventive actions plan: displacement of the form separation within the injection molding tool "(b)(4)" out of the sealing groove of component "filterlid" (70103.0908).Initial sample testing of new components, due date: 2018-04-30.Displacement of the form separation within the injection molding tool "(b)(4)" for both cavities out of the sealing groove of component "bloodoutletlid" (70103.0905) initial sample testing of new components, due date: 2018-04-30.

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: 7028620
• MDR Text Key: 93075148
• Report Number: 8010762-2017-00360
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K090689
• 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: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2019
• Device Model Number: HMO 71000 J
• Device Catalogue Number: 701048762
• Device Lot Number: 70115445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2017
• Date Device Manufactured: 01/01/2017
• 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