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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING SETS; TUBING, PUMP, CARDIOPULMONARY BYPASS
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MAQUET CARDIOPULMONARY GMBH TUBING SETS; TUBING, PUMP, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BE-MECC 101403#MECC SYSTEM W/O RESERVOIR
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/13/2023
Event Type  malfunction  
Manufacturer Narrative
A follow-up medwatch will be submitted when further information becomes available.
 
Event Description
It was reported that hole was found on tyvek during unpacking the product and there was not any damage detected on the outer box (cardboard box).Therefore, the product was not used for treatment.No harm to any person has been reported.Complaint # (b)(4).
 
Manufacturer Narrative
It was reported that hole was found on tyvek during unpacking the product and there was not any damage detected on the outer box (cardboard box).Therefore, the product was not used for treatment.No harm to any person has been reported.The sample investigation is not required at this time.The reported failure is already known by manufacturer.Based on this, the failure could be confirmed.The production history records (dhrs) of the affected be-mecc 101403 with lot# 3000321352 was reviewed on 2023-10-25.According to the dhr results, the product be-mecc 101403 passed the defined manufacturing and final release specifications.Further, quality hold has been initiated for the product ¿be-mecc 101403 / 701075208, v04¿.Capa has been initiated for the reported failure ¿hole at tyvek / tyvek perforated¿ and for the reported product ¿be-mecc 101403 / 701075208¿.The root cause analysis and further actions to determine corrective measures for the failure will be performed within the capa.Root cause investigation has been performed in scope of capa.Based on the investigation results, most probable causes have been determined as: - root cause 1: worstcase selection doesn¿t cover tubing set quadrox-ir configuration with standard tray.Also, quadrox-i&id isn¿t assembled to reservoir configuration with standard tray.- root cause 2: there is not clear requirement defined for evaluation of packaging configuration in si-b-319 rev07 and its form sheets.- root cause 3: there is an inadequate specification/rule for packaging configuration of tubing set.- root cause 4: there is insufficient awareness about evaluating the suitability of possible configurations in terms of packaging other than the existing drawings.- root cause 5: the protective tube assembled to the sharp edge on the top of quadrox-ir does not provide sufficient protection.All further steps will be performed in accordance to the capa the occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.
 
Event Description
Complaint #(b)(4).
 
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Brand Name
TUBING SETS
Type of Device
TUBING, PUMP, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
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Manufacturer (Section G)
JULIA KAPFENBERGER
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Manufacturer Contact
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MDR Report Key17773064
MDR Text Key323720367
Report Number8010762-2023-00467
Device Sequence Number1
Product Code DWE
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K080592
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBE-MECC 101403#MECC SYSTEM W/O RESERVOIR
Device Catalogue Number701075208
Device Lot Number3000321352
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/26/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/08/2023
Is the Device Single Use? Yes
Type of Device Usage A
Patient Sequence Number1
Patient Outcome(s) Other;
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