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

Device Problems Device Alarm System (1012); Circuit Failure (1089)

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

Event Date 08/18/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Description from the customer report: cardiohelp circuit change for venous alarms that we treated overnight with fluid boluses until customer found out this morning and insisted on changing the circuit without any further interventions.And now the flows are being read much better and venous pressure is way more appropriate.The circuit was only 5-6 days old.Not sure why this keeps happening.(b)(4).

Manufacturer Narrative

(b)(4).The hls module advanced 7.0 was returned to the factory and investigated in the decontamination / complaints laboratory.No blood clots were visible on flushing out the oxygenator.The dialysis connector was found to be clotted.For further examination, the product was forwarded to the qa laboratory.In the qa laboratory, the product was tested for its gas exchange performance for o2 and co2, and also a pressure drop test was performed.The product passed the gas exchange performance tests, but failed the pressure drop test, confirming the customer's reported issue.The product was then sent back to the decontamination / complaints laboratory, where all four sides of the oxygenator were sawn open, and the mats were inspected for any signs of damage, marks or any other anomalies.No anomalies were found.The number of gas mats was also counted, and there are 74 (a count of 72, 74, or 76 is specified).There were no signs of any clotting between the mats, or anything else of note.In conclusion, the results of the pressure drop test supports the customer's reported issue, however internal examination of the oxygenator found no anomalies, so a clear root cause could not be established.Based on the investigation and trending for this issue, a systemic issue is not indicated (this is an isolated case), therefore no further investigation or action is currently warranted in addition to continued periodic monitoring, and the complaint will be closed.

Event Description

Ref.: # (b)(4), customer ref.: (b)(4).

• Brand Name: HLM TUBING SET
• 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: 5949647
• MDR Text Key: 55111891
• Report Number: 8010762-2016-00564
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K053025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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