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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
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MAQUET CARDIOPULMONARY AG HLM TUBING SET W/BIOLINE COATING Back to Search Results
Device Problems Device Operates Differently Than Expected (2913); Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Event Description
(b)(4).
 
Manufacturer Narrative
(b)(4).The prod has not been requested back for investigation is the laboratory of the mfr as the failure is already known.The malfunction has been thoroughly investigated within a previous complaint.The device was cleaned and a performance test was executed.The device passed the established specification for performance testing.Therefore the cause of this failure was determined not to be attributed to a device related malfunction.This data will be handled through a designated maquet trending process.A supplemental medwatch will be submitted if add'l info becomes available.(b)(4).Add'l info: the prod mentioned is a tubing set and the included affected component has the contributing design function of the quadrox-id which is registered.
 
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Brand Name
HLM TUBING SET W/BIOLINE COATING
Manufacturer (Section D)
MAQUET CARDIOPULMONARY AG
rastatt
GM 
Manufacturer Contact
michael campbell
kehler strabe 31
rastatt 76437
GM   76437
2229321132
MDR Report Key4809432
MDR Text Key5920581
Report Number8010762-2015-00658
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 Health Professional,User Facility,Company Representative
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Other
Date Manufacturer Received05/05/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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