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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

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MAQUET CARDIOPULMONARY AG HLM TUBING SET; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE Back to Search Results
Model Number H 99100
Device Problem Contamination (1120)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/13/2016
Event Type  malfunction  
Event Description
(b)(4).
 
Manufacturer Narrative
Maquet cardiopulmonary (b)(4) will not be able to investigate the product as it will not be available for manufacturer's investigation.Due to the internal clinical assessment it is possible that a higher traumatization of the blood could be given which leads to a higher clotting risk.Anyway these factors are always given when a heart-lung-machine is used.The manufacturer is aware of a similar complaint showing a similar malfunction.This similar event occurred at the same hospital.The products of this similar complaint has been requested but were not received.As soon as the investigation of this similar complaint has been finished a supplemental medwatch will be submitted.Additional information: the product mentioned under section is a tubing set and the included affected component has the contributing design function of the blood filter which is registered under 510(k): k001787.
 
Event Description
Description from the customer report: "after priming procedure and starting circulation perfusionist noted filter pall al3 is conversely mounted.Unfortunately blood was already in.There was no consequence for patient.Contaminated set is not available for investigation." (b)(4).
 
Manufacturer Narrative
The received complaint has been investigated by (b)(4).Thereby a device history record of the reported lot has been investigated and no abnormality was found.All the controls were done according to the process control form.Moreover, no scrap record for the related pall filter was found.Based on the received picture the reported failure could be confirmed by maquet (b)(4).The most probable cause was determined as a failure caused by a operator mistake.As a corrective action a training has been performed with the explanation of the assembly of the filter.Furthermore the operators of maquet turkey have been informed about the complaint.As soon as further information becomes available a supplemental medwatch will be submitted.
 
Event Description
(b)(4).
 
Manufacturer Narrative
(b)(4).Maquet cardiopulmonary (b)(4) will not be able to investigate the product as it will not be available for manufacturer's investigation for the complaint #(b)(4), because contaminated set was throwed away by hospital.On the other hand,4 sets were available for investigation, and the product was received for evaluation under complaint #(b)(4).Based on this investigation, the filter has been inspected visually and it was found that the filter has been installed incorrectly.Additionally, the received complaint has been investigated by maquet cardiopulmonary (b)(4).Thereby a device history record of the reported lot has been investigated and no abnormality was found.Based on the received picture the reported failure could be confirmed by maquet (b)(4).The most probable cause was determined as a assembly failure caused by an operator mistake.As a corrective action a training has been performed with the explanation of the assembly of the filter.Furthermore the operators of maquet (b)(4) have been informed about the complaint.Additionally, a review for similar complaints for the specific product has been performed and no similar incident with a failure confirmed was found.This data will be handled through a designated maquet trending 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 action will be completed at this time.
 
Event Description
(b)(4).
 
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Brand Name
HLM TUBING SET
Type of Device
FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
Manufacturer (Section D)
MAQUET CARDIOPULMONARY AG
rastatt
GM 
Manufacturer (Section G)
BERND RAKOW
maquet cardiopulmonary ag
kehler strasse 31
76437 rastatt 76437
GM   76437
Manufacturer Contact
maquet cardiopulmonary ag
kehler strasse 31
76437 rastatt 76437
4972229321
MDR Report Key5772914
MDR Text Key49538437
Report Number8010762-2016-00426
Device Sequence Number1
Product Code DTM
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K001787
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 04/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/01/2017
Device Model NumberH 99100
Device Catalogue Number70106.3568
Device Lot Number92165707
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/13/2016
Initial Date FDA Received07/06/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Supplement Dates FDA Received07/08/2016
08/12/2016
04/06/2017
Date Device Manufactured05/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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