MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HL-20 INTEGRATED PERFUSION SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Device Problems Air Leak (1008); Device Alarm System (1012); Device Inoperable (1663)

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

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As stated by the customer: had a mass entrainment of air into the venous line, which suddenly dropped my level whilst at full flow.The level subsequently dropped to 25 ml on the reservoir and a small amount of air was entrained into the pump boot and oxygenator.The level alarm monitoring did not sound or regulate the pump.This air was immediately purged and did not go any further through the circuit.The patient was unharmed.The reason for the sensor failure is essentially unknown, but a couple of contributing factors may have lead to it: the position of the sensor was such that the blood cascading from around the back of the reservoir shelf may".No harm of the patient has been reported.(b)(4).

Event Description

Internal reference:(b)(4).

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary(b)(4).Rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).Importer- maquet medical systems usa (b)(4).Contact person- (b)(6).The product in charge is not available for investigation therefore no laboratory investigation is possible.Investigation by ssu uk, information came on (b)(6)2018: the used reservoir is not an mcp product, but a medtronic affinity nt.Perfusionist is not sure if the pad was used from the set of medtronic.It seemed to overcome the problem by placing a second pad on the middle of the reservoir.Bad positioning could be the cause of the alarm.Thus the failure could not be confirmed.Most possible root cause could be determined as user error.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.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.

• Brand Name: HL-20 INTEGRATED PERFUSION SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7533597
• MDR Text Key: 109106519
• Report Number: 8010762-2018-00174
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Initial Date Manufacturer Received: 05/05/2018
• Initial Date FDA Received: 05/22/2018
• Supplement Dates Manufacturer Received: 05/05/2018
• Supplement Dates FDA Received: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1