MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG OXYGENATOR, CARDIOPULMONARY BYPASS; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number HMO 71000

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

"during priming, leakage from the connector tube at the dialysis lock occurred.Replaced the connector with another one from a different lot to continue the procedure.-no adverse effect on the patient.(b)(4).

Manufacturer Narrative

(b)(4).An original packed oxygenator and an adaptation piece were received and the product was investigated in the laboratory of the manufacturer.The adaptation piece line is damaged.A tightness test with a water pressure of 0,5 bar was performed and hereby a leakage due to the damage/ hole on the tube could be confirmed.The leakage point was examined with a microscope and a flow line was detected.It is probable that a granulate was not melted during the production of the tube, and a leak has developed.Thus the reported failure could be confirmed.Since the reported failure did not contribute to a death serious injury and no systemic issue could be determined.No corrective action is needed at this time.The failure was determined to be the first of its kind and 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: TUBING, PUMP, 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: 6650673
• MDR Text Key: 78030887
• Report Number: 8010762-2017-00195
• Device Sequence Number: 1
• Product Code: DWE
• 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: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2018
• Device Model Number: HMO 71000
• Device Catalogue Number: 701048762
• Device Lot Number: 70114750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1