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U.S. Department of Health and Human Services

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

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MAQUET CARDIOPULMONARY AG HLM TUBING SET W/BIOLINE COATING OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BEQ-HLS 7050-CA
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Code Available (3191)
Event Date 01/16/2016
Event Type  malfunction  
Manufacturer Narrative
Feb. 11, 2016 10:24 am (gmt-5:00) added by (b)(6): (b)(4). Maquet cardiopulmonary (b)(4) requested the product back for investigation but has not received it until yet. Investigation is still pending.
 
Event Description
Feb 11, 2016 10:10 am (gmt-5:00) added by (b)(6): customer noted the --- in venous pressure and a message saying venous probe disconnected. Also noted that it's reading part and pint without problem. Customer changed the cable with the same result. --- would indicate out of range values but the line was soft and not pressurized. It was impossible to stop the alarm. A +85mmhg as the negative pressure reading. This value appeared all of a sudden when the --- disappeared. This +85mmhg hasn't changed even if they modify rpm or give volume to the patient. However, if the patient becomes hypovolemic, the flow will drop until fluid is given to the patient. The +85mmhg never changes. (b)(4).
 
Manufacturer Narrative
The item was returned to maquet for investigation, which took place on (b)(6) 2016. The hls module was connected to the cardiohelp device. A tightness test was performed and a leakage at the luer lock on the blood outlet connector was discovered and therefore the system could not be pressurized. The crack was sealed with glue, so that further tests could be carried out. The hls module was connected to the cardiohelp device once again, and all parameter values were displayed. No further issues were found. However, the manufacturer is aware of similar complaints showing a similar malfunction where customers described a drift of the venous pressure sensor readings, resulting in alarms and /or implausible pressure values. An internal non-conformance (nc (b)(4)) was initiated to determine the most probable root cause and to implement appropriate corrective action. The investigation found that the flex pcb of the venous pressure sensors of the oxygenators in question can corrode. A white crystalline substance has been found on the pins of the pressure sensor. The priming solution leads to electrolysis when the cardiohelp device starts to work. The electrolysis starts immediately and causes a short circuit between the pins. The short circuit leads to implausible sensor pressure readings. It could be shown by a dried electrolyte plug that this state has no obvious impact on pressure sensor readings. The investigation concluded that the varnish used on the flex pcb and pressure sensor pins is not completely resistant to the electrolysis effects related to the saline priming solution (the electrolyte etches the pins of the flex pcb). A new, more resistant coating for the flex pcb is currently being developed within nc (b)(4).
 
Event Description
(b)(4).
 
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Brand NameHLM TUBING SET W/BIOLINE COATING
Type of DeviceOXYGENATOR, 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 Key5430726
MDR Text Key38701173
Report Number8010762-2016-00073
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K101153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/01/2017
Device Model NumberBEQ-HLS 7050-CA
Device Catalogue Number70106.4847
Device Lot Number70106716
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2015
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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