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

Model Number BE-HLS 7050

Device Problems Defective Device (2588); Device Displays Incorrect Message (2591)

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

Event Date 05/28/2016

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet (b)(4).The product was requested for manufacturer's laboratory investigation but has not been received.The investigation is pending.A supplemental medwatch will be submitted when additional information becomes available.

Event Description

According to the hospital, the monitoring of the venous pressure was defective.The alarm [pven sensor disconnected] was displayed while the pressure cable was connected.The alarm starting ringing at the priming.There is no possibility to turn off this alarm except using the override mode.The patient is still connecting to the circuit and no consequence was reported so far.The hospital will keep the affected component when the ecmo procedure on the patient ends.It will be available at that time.The hospital could not use another circuit to treat the patient because they had no other product in stock (due to maquet delivery issues).(b)(4).

Manufacturer Narrative

The product was scrapped by the hospital; therefore a manufacturer laboratory investigation was not possible.Based on this it was also not possible to perform a dhr review, as the lot # of the set and hls module self is unknown and could not be obtained anymore.Maquet cardiopulmonary (b)(4) is aware of similar complaints which have been thoroughly investigated under (b)(4).First time failure investigation done with the following outcome: the product has been investigated in the laboratory of the manufacturer.A tightness test was performed, the hls module was tight.During further examination humidity within the pump housing was detected as well as strongly oxidized pressure sensor at the blood inlet connector.This could be the most probable cause for the measurement malfunction.Additional investigations of oxygenators under (b)(4) were showing that the venous pressure sensors are probably corroded.A white crystalline substance was found on the pins of the pressure sensor.The priming solution leads to an electrolysis when cardiohelp starts to work.The electrolysis starts instantly and causes a "short circuit" between the pins.The "short circuit" furthermore leads to implausible sensor pressure readings.The most probable root cause is that varnish applied on pcb and plugs of venous pressure sensor does not resist the etching of the saline.Corrective actions will be implemented as soon as the root cause investigation under (b)(4) is completed.Based on this no further actions will be completed at this time.

Event Description

(b)(4).

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: TUBING, PUMP, 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: 5729984
• MDR Text Key: 48521012
• Report Number: 8010762-2016-00392
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K080592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-HLS 7050
• Device Catalogue Number: 701047753
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2016
• 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