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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY AG QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BEQ-HMOD30000-USA
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/04/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). A supplemental medwatch will be submitted when additional information becomes available. (b)(4).
 
Event Description
It was reported that delta p began increasing and the circuit was changed approximately 36 hours after initiation of therapy. Initiated support (b)(6) 2016 at 20:40, flow ~400 to patient (~500 through mo) at 1600-1800 rpms, transmembrane pressure ~22. Transmembrane pressure at 12 hrs ~22, at 24 hrs ~27, at 30 hrs ~32, then 39, 38, 37, 69, 67, and 63 each hr after the (b)(6). After the membrane change out the transmembrane pressure has been between 16-18 at the same flow and rpm ranges, for over 30 hrs with similar lab values. Acts ranged from 102-196 (very common values, have many runs with 100-120 acts for >16hrs without complications) during the first 11 hrs; 213-267 for the next 8 hr shift; 158-210 for the 3rd shift, at this point no delta p issues. 202-231 during the 4th shift; 216-354 during the 5th shift, during which the delta p began increasing and the circuit was changed at ~9:30. (b)(6) 2016, roughly 36+ hours after initiation. Anti xa levels (target 0. 4-0. 6) were: 0. 53, 0. 67, & 0. 6 for day one, 0. 88 & 0. 49 for day two (when delta p increased). Ptt (target 60-90) was 96, 89 & 99 for day one, 76 & 60 for day two (delta p incr). Teg kaolin:kaolin heparinase r ratio (target 3-5) was 2. 4:1 on the first morning & 6 to 1 on the morning of the delta p increase & required change-out. Anti-thrombin levels were 124-126 during this time frame. Platelet count was 105, 104 & 94 for day one, 82 & 83 for day two. Fibrinogen level was 207, 208 & 206 for day one, 177 & 173 for day two. Dark clot or debris on the inlet side beyond the sparger plate was seen after rinsing. (b)(4).
 
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Brand NameQUADROX-ID PEDIATRIC DIFFUSION MEMBRANE
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY AG
rastatt
GM
Manufacturer (Section G)
MICHAEL CAMPBELL
maquet cardiopulmonary ag
kehler strasse 31
rastatt 76437
GM 76437
Manufacturer Contact
maquet cardiopulmonary ag
kehler strasse 31
rastatt 76437
MDR Report Key5392959
MDR Text Key36899103
Report Number8010762-2016-00044
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
PMA/PMN Number
K100278
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
Report Date 01/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/01/2016
Device Model NumberBEQ-HMOD30000-USA
Device Catalogue Number701050330
Device Lot Number70103435
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/04/2016
Event Location Hospital
Date Report to Manufacturer01/04/2016
Date Manufacturer Received01/04/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/01/2014
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: 01/27/2016 Patient Sequence Number: 1
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