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

Model Number BEQ-HMOD30000-USA

Device Problems Device Operates Differently Than Expected (2913); Filtration Problem (2941)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/06/2015

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2015 01:57 pm (gmt-5:00) added by (b)(6) ((b)(4)): (b)(4).The device has been requested but not yet received.A supplemental medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

It was reported a clot was noticed on the arterial face of 2 day old oxygenator, which looked like fiber pattern.Coags haven't been super low but flow was a little lower because patient was only (b)(6) kg.Device was swapped out.No consequence for the patient.(b)(4).

Manufacturer Narrative

(b)(4).Product was received for the manufacturers laboratory investigation.A visual inspection was performed.Thereby clotting could be visual identified on arterial side.Product was rinsed out with water but no clots could be visual inspected.For further investigation the product will be tested regarding its performance and pressure drop performance.Investigation is still pending.

Event Description

(b)(4).

Manufacturer Narrative

In the laboratory investigation, some clotting could be visually identified on the arterial side.However, the oxygenator's performance was tested in the qa-laboratory and was found to be within the specified range.The cause of the clotting as reported by the customer does not appear to be related to the product, so most probably is attributed to clinical factors, such as the anti-coagulation measures deployed.A definitive root cause for the customer's issue cannot therefore be ascertained.Investigation of this complaint and trending for this issue does not indicate a systemic issue.As a product malfunction is not indicated based on the investigation results, no further investigation or action is warranted at this time and the complaint will be closed.

Event Description

(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): 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 Key: 5257068
• MDR Text Key: 32362874
• Report Number: 8010762-2015-01196
• 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,Followup,Followup
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2016
• Device Model Number: BEQ-HMOD30000-USA
• Device Catalogue Number: 70105.0330
• Device Lot Number: 70101575
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/15/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/09/2016
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/06/2015
• Initial Date Manufacturer Received: 11/06/2015
• Initial Date FDA Received: 12/01/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/19/2016; 11/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention