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

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).

• Brand Name: QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE
• Type of Device: OXYGENATOR, 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 Key: 5392959
• MDR Text Key: 36899103
• Report Number: 8010762-2016-00044
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K100278
• Number of Events Reported: 1
• 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 Received: 01/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/01/2016
• Device Model Number: BEQ-HMOD30000-USA
• Device Catalogue Number: 701050330
• Device Lot Number: 70103435
• 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 Date: 01/04/2016
• Event Location: Hospital
• Date Report to Manufacturer: 01/04/2016
• Date Manufacturer Received: 01/04/2016
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 12/01/2014
• 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