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

Model Number HMO 71000-J

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the customer: during the tumor excision and tap surgery, the customer assembled the circuit, completed priming and started cpb on at 12:53p.M.About 40min.After pump on, some blood droplets found on the floor.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 3:51 p.M.The surgery was finished with no impact from this incident.Pulsatile flow was not used.-no adverse effects on the patient.Ref.: #(b)(4).

Manufacturer Narrative

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.The oxygenator was cleaned with sodium hypochlorite solution.A tightness test was performed and a leakage on the dialysis lock and valve was confirmed hereby.No other abnormalities were detected.Thus the reported failure could be confirmed.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).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

(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: 6872972
• MDR Text Key: 87743914
• Report Number: 8010762-2017-00304
• 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: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• 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: 09/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2017
• 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