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

Model Number HMO 71000-J

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 09/03/2017

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

The customer used the hmo71000 for the surgery of the replacement of ascending thoracic aorta, and started cpb on at 8:41p.M.About 9:00 pm, the customer checked the oxygenator and found the blood was oozing from the dialysis lock valve.It was not much leakage, the customer continued to use the device and pcb off at 11:56 p.M.The surgery was finished with no impact from this incident.-no adverse effects on the patient.(b)(4).

Manufacturer Narrative

(b)(4) requested the product for investigation but the product was not available.The failure is already known to the manufacturer and has been thoroughly investigated under a previous complaint.The investigation results of this similar complaint are as follows: the product was investigated in the laboratory of the manufacturer.By visual inspection it was determined that within the dialysis lock and valve was blood.A tightness test was performed and a slight leakage was confirmed hereby.Thus the reported failure could be confirmed.The most probable cause of the reported failure is the detected offset which caused a leakage of the o-ring.Besides that mcp has decided, based on several complaints for the dialysis lock and valve showing the same symptoms with different material numbers than the one in this complaint, to initiate another capa (corrective and preventive action) in order to determine the root cause and initiate further actions to determine corrective measures for the failure as well as to clarify whether a systemic issue is present.All further steps will be performed in accordance to (b)(4).Additionally the data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations than the above mentioned will be completed 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: 6936511
• MDR Text Key: 89616258
• Report Number: 8010762-2017-00335
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082117
• 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: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2019
• Device Model Number: HMO 71000-J
• Device Catalogue Number: 701048762
• Device Lot Number: 70115449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2017
• Date Device Manufactured: 03/01/2017
• 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