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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 USA
Device Problems Device Displays Incorrect Message (2591); Pressure Problem (3012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/05/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The product was not requested to return for laboratory investigation as the failure is already known to the manufacturer and has been thoroughly investigated under (b)(4). An investigation of oxygenators in question showed that the venous pressure sensors are probably corroded. A white crystalline substance has been 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. It could be shown by a dried electrolyte plug that this state has obvious no impact on pressure sensor readings. It is obvious that the electrolyte (saline - priming solution) etches the pins of the plug. 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. Based on these results (b)(4) will be closed. The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process. If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation initiations will be completed at this time. Additional information: the product mentioned is a tubing set and the included affected component has the contributing design function of the quadrox-id which is registered under 510(k): k101153.
 
Event Description
Description from the customer report: "a call from customer was received at 5:56pm. Customer reported that they were having problems with the integrated pressures. Customer said that ever since the initiation of the cardiohelp on the patient, the pven has been going from +600 mmhg to -300 mmhg. The pint and the part seem to be functioning ok. Soon after the sporadic numbers on the pven all it would read was dashes. The alarm continually went off reading no pven connection. Customer was advised to check the integrated pressure cord on the machine. See if it's loose and try a new one. If it continues may want to consider changing the hls set. This occurred at 6:42pm. Customer tried the hls set in another machine, it was the same. They checked the cord with no change. They ended up changing out the hls set. New hls set works fine. There were no consequences to the patient" (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 Key5799705
MDR Text Key50631152
Report Number8010762-2016-00462
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
PMA/PMN Number
K101153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/05/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBEQ-HLS 7050 USA
Device Catalogue Number70105.2794
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/05/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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