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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY AG OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number VKMO 78000
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Death (1802); Low Oxygen Saturation (2477)
Event Date 02/20/2018
Event Type  Death  
Manufacturer Narrative
(b)(4). A follow-up medwatch will be submitted when additional information becomes available. (b)(4). Device requested but not returned.
 
Event Description
According to the hospital: "(b)(6) years old male undergoing cabg+vsr repair on (b)(6) 2018. Went on cpb and first pao2 (31 minutes after cpb established)was 259. After 161 minute, pao2 dropped to 125 mmhg, fio2 was increased to 0,8. After another 25 minutes, pao2 further dropped to 74 mmhg. Oxygen supply source was immediately checked and evaluated as pre-caution, but arterial blood remained deoxygenated. Oxygenator had to be changed while patient was fully rewarmed but still in asystole. " (b)(4).
 
Manufacturer Narrative
(b)(4). A follow-up medwatch will be submitted when additional information becomes available. Reference exemption # (b)(4) importer- (b)(4). Contact person- (b)(6). The lot number of the set was requested at least three times from the ssu, but, they could not reach the exact lot number of the claimed set. Therefore, device history record could not be reviewed. Additionally, the sample was discarded by the hospital. Sap trend search was performed (material (b)(4), similar failure) which came to following results: no additional complaint was recorded. Based on the sales figures of the last 12 months following occurrence rate has been calculated: 0%, which is below 1%. Due to this information no systemic issue could be determined. As it is not possible to investigate further in this case, it is not possible to determine a clear root cause for the failure. Based on the insufficient information regarding to complaint, the failure could not be confirmed. The data is being handled through a designated maquet cardiopulmonary trending and applicable investigation process. Due to this no further investigation initiations will be completed at this time.
 
Event Description
(b)(4).
 
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Brand NameOXYGENATOR, CARDIOPULMONARY BYPASS
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 Key7553092
MDR Text Key109542863
Report Number8010762-2018-00191
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodePK
PMA/PMN Number
K082117
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberVKMO 78000
Device Catalogue Number701064525
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received08/15/2018
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

Patient Treatment Data
Date Received: 05/30/2018 Patient Sequence Number: 1
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