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U.S. Department of Health and Human Services

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

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MAQUET CARDIOPULMONARY AG HLM TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BEQ-015703112
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/26/2016
Event Type  malfunction  
Manufacturer Narrative
Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(6). Maquet cardiopulmonary (b)(4) requested the product back for investigation but has not received it. Investigation is still pending. Additional information: the product mentioned under section d is a tubing set and the included affected component has the contributing design function of the quadrox-id which is registered under 510(k): (b)(6).
 
Event Description
It was reported the customer plugged in the pressure cable on their cardiohelp unit. The venous pressure displayed --- on the screen. Arterial pressure and internal pressure, as well as, the arterial temperature were displayed with normal values. Cable was unplugged and re-plugged in, but this did not resolve the issue. Cable was swapped with other cardiohelp hardware and this did not resolve the issue. Incident occurred during priming. (b)(4).
 
Manufacturer Narrative
Attempts for the sample to be returned were made but the sample was not received and therefore it was not possible for a full investigation to be performed. It was established that the article/material number was in fact 70105. 4379 for beq-015703112#hls module, and not 70105. 2794 for beq-hls 7050 usa#hls set. The issue was initially considered to be consistent with the issue investigated in (b)(4), but as the product was not available for investigation, it has not been possible to establish a definitive root cause, and the issue will not be related to (b)(4) with the currently available information. A dhr review of lot 70105475 was performed and the investigation found no abnormalities and all the controls were completed in accordance to the process control form. A search of the complaint handling database was also carried out on 2017-03-09 and no similar complaints were found matching the customer's reported issue. Based on the available information, a root cause cannot be determined. No health risk or patient impact has been identified. No systemic issue was identified from the complaint database review but the data, however, will continue to be monitored and 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 or action is warranted at this time and the complaint will be closed. This is the final report.
 
Event Description
(b)(4).
 
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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 Key5450610
MDR Text Key39260702
Report Number8010762-2016-00095
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 03/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBEQ-015703112
Device Catalogue Number701054379
Device Lot Number70105475
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received03/13/2017
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

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