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

Catalog Number 701048012

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Date 08/28/2015

Event Type  Death  

Manufacturer Narrative

Additional information: the product mentioned is a tubing set and the included affected component has the contributing design function of the quadrox-id which is registered under 510(k): k101153.(b)(4).The device has been requested for return; but not yet received.A supplemental medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).

Event Description

It was reported a patient was on cardiohelp providing veno-venous support using two femoral cannulae.Received two bubble alarms; the bubble intervention was not being utilized.After the second alarm a pocket of air in the post membrane side of the hls was noted.It was described as starting about 1/2 inch above the dia-con connector and extending to the top of the apex.Support parameters were reported to be: flow: 0.8-1.2 lpms, rpms: 1905, pven -63 mmhg, part 46 mmhg, pint 46 mmhg.Flow never above 2 liters/min.Air never pulled down to the outlet.An attempt to remove the air was made by removing the cap on the hydrophobic filter; with no change.An attempt to remove the air using the pig-tail was also not successful.Only blood was aspirated; not air.It was determined that the patient was being adequately supported and the current course would be continued without further attempt to remove the air pocket.The next morning, the customer reported that the situation had not changed and that they felt that the patient was well supported.After a few days the air was gone; appeared to slowly dissolve into the blood.Treatment was from 21:30 (b)(6) 2015 until 05:00 (b)(6) 2015; when the patient expired.As relayed by the customer, the death was not as a result of the device, but due to the patient's condition.(b)(4).

• Brand Name: HLM TUBING SET
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MICHAEL CAMPBELL; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437
• MDR Report Key: 5102331
• MDR Text Key: 26714323
• Report Number: 8010762-2015-01062
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Report Date: 08/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 701048012
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/28/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2015
• Date Manufacturer Received: 08/28/2015
• 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): Death