MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLS SET; HLM TUBING SET W/BIOLINE COATING

Device Problems Filtration Problem (2941); Improper Device Output (2953); Output Problem (3005)

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

Event Date 11/20/2014

Event Type  Injury  

Event Description

It was reported that the diagnostic systems of the hls module had been showing no values during therapy.First the venous inlet pressure was not measurable.After a few days of therapy, the flow sensor showed no value.The pump was stopped for a zero balance.Afterwards, the values were measurable.At the end of therapy, a blood clot was present (without delta p increase).The pump was stopped and another hls set was used.There was still significant color difference of the evacuative and afferent tubes during the stoppage of gas flow.After reducting the oxygen concentration to 21% at the gas blender, no color difference was visible in the tubes.No reported patient effect.(b)(4).

Manufacturer Narrative

The investigation is still pending.A supplemental medwatch will be submitted when additional information becomes available.

• Brand Name: HLS SET
• Type of Device: HLM TUBING SET W/BIOLINE COATING
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4337867
• MDR Text Key: 5176078
• Report Number: 8010762-2014-01356
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• Is this an Adverse Event Report?: Yes
• 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: 11/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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