MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG OXYGENATOR, CARDIOPULMONARY BYPASS; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Model Number HMO 51000-J

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/30/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product was requested for manufacturer's laboratory investigation but was not yet returned.The investigation is still pending.A supplemental medwatch will be submitted when further information becomes available.

Event Description

According to the customer: the incident occurred during the device was in use for the surgery on (b)(6) 2016, 60 min.After the extracorporeal circulation started: it was observed that the bubbles were spouting from the gas inlet port at upper part of the oxygenator the customer found the reddish liquid, which may have been spouting from the port, on the floor under the oxygenator.It was observed that the reddish liquid adhered to the body of the oxygenator, around the area of the port.(b)(4) (distributor) was contacted (11:49am?) confirmed that there is no problem on the gas exchange ability.Told the customer to close the cap of the port in question.(b)(4) visited the hospital.Confirmed that the problem solved after the customer closed the cap.(b)(4).

Manufacturer Narrative

The oxygenator was cleaned and a circuit with an hl20 was created.A fluid leakage out of the de-airing membrane was confirmed.Based on this the failure "bubbles spouting from the de-airing port" could be confirmed.The failure is known to maquet cardiopulmonary and was thoroughly investigated by (b)(4).Corrective and preventive actions have been established in (b)(4) based on the root cause analysis.Development and implementation of an optical inspection of the (b)(4) (membrane).Development and implementation of a new punching process.Improvement of the packaging of the membrane rolls at the supplier.Prevention of pressures above the tolerance in pressure test units (revision/enhancement of basic operating procedures).Full further investigation and all other actions and the effectiveness thereof, will be carried out as part of the capa investigation.

Event Description

(b)(4).

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• 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: 5735819
• MDR Text Key: 47741599
• Report Number: 8010762-2016-00396
• Device Sequence Number: 1
• Product Code: DTM
• 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: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2018
• Device Model Number: HMO 51000-J
• Device Catalogue Number: 701048782
• Device Lot Number: 70110881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2016
• Initial Date FDA Received: 06/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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
• Patient Outcome(s): Required Intervention