• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAQUET CARDIOPULMONARY AG HLM TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number HLS SET
Device Problems False Reading From Device Non-Compliance (1228); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Maquet cardiopulmonary (b)(4) requested additional information regarding this complaint but none was received until yet. Investigation is still pending. A supplemental medwatch will be submitted as soon as further information becomes available. Additional information: the product mentioned under 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: "customer claimed that the part was reading a negative number while flowing forward. Rpm's were approximately 2600, flow was 1. 8 lpm, pven was -212, and p-art was -38. Prior to calling the maquet support line customer had turned down the rpm's and clamped the arterial and venous lines and re-zeroed the pressure transducers on the cardiohelp. There also was concern by the account that the avalon cannula could be out of position. The patient was being supported sufficiently through this call and the account was going to check cannula position in the morning. Local ptm notified. " (b)(4).
 
Manufacturer Narrative
Additional information has been evaluated with the internal therapy application manager. Based on that the reported erroneous arterial pressures were due to the fact that the cannula needs to be repositioned. As the cannula has been repositioned the pressure readings got normal and the problem was solved. Based on the received information no failure of the hls set occurred and therefore no investigation is needed. Due to this complaint # (b)(4) is 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 is necessary. Due to this no further investigation initiations will be completed at this time.
 
Event Description
(b)(4). Additional information received on 09/07/2016: "customer said that the hls set was showing negative values due to the fact that the cannula was in the hepatic vein and needed to be repositioned. Once the surgeon repositioned the cannula the pressure readings on the hls set normalized and was functioning correctly. They kept the patient on the hls set for 72 hours and then weaned him successfully off. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHLM TUBING SET
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 Key5890785
MDR Text Key53596750
Report Number8010762-2016-00532
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,Followup
Report Date 08/09/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHLS SET
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 Received09/07/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-