MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLM TUBING SET W/BIOLINE COATING; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number BE-HLS 7050#HLS SET ADVANCED 7.0

Device Problem No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2019

Event Type  malfunction  

Event Description

They reported that the internal pressures on the hls set are completely out of range.They jump from very high values to low values.Pressure cable was changed out, but no effect.Re-calibrating the pressures also did not help.Patient was on the device.No harm was done.New information was received on (b)(6) 2019: they changed cables, hardware etc.But the error still occurred.Thus the set was replaced during therapy.Internal ref.# (b)(4), onesupport # (b)(4).

Manufacturer Narrative

Maquet cardiopulmonary gmbh requested the affected product for return on 2019-09-26.Sample received on 2019-10-07.The returned product was investigated in the laboratory of the manufacturer on 2019-11-21.A hls module advanced 7.0 was returned.The sample was cleaned with sodium hypochlorite.The protective cover of the pump was removed.The pven showed no abnormalities.On the pint (delta p) sensor the adhesive as well as the adhesive membrane dissolved.The adhesive membrane is yellowish discoloured (got wet by priming solution).On the part sensor the adhesive has also dissolved and the adhesive membrane is yellowish discoloured.The module was connected to the cardiohelp.All pressure values were stable.Short time (approx.6 min) later the sensors part and delta p failed to work.Thus the reported failure could be confirmed.The most probable root cause is that the sensors became wet (see the yellow discoloration) and caused the sensors to malfunction.The device was directly involved in the reported incident and was used for treatment of the patient when the event occurred.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Internal ref.# (b)(4), onesupport # (b)(4).

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9202359
• MDR Text Key: 200639874
• Report Number: 8010762-2019-00330
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K080592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-HLS 7050#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701047753
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Date Manufacturer Received: 11/27/2019
• Patient Sequence Number: 1