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

Model Number HQV 101700

Device Problems Decrease in Pressure (1490); Increase in Pressure (1491)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been requested but not received.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the customer: "patient undergoing elective cabg due to functional 3-vd.Hypertension and hyperlipidemia.Good left ventricular function.Per operative lab essentially without any remark: hb 140g/l, tpk 221, at iii 1.04 kiu/l, apt-t 24.8s, fibr 4.32 g/l.Progress: start of cpb without remarks, act 678 after starting the cpb.During the first 15-20 min of perfusion the pre-membrane pressure rises to max 500 mmhg, nothing during inspection explains the raised pressure.The pressure after the oxygenator is 180 mmhg which leads to a pressure drop of 58.2 mmhg/l (flow rate was 5.5l/min).Warming of the patient starts from 34.0 degrees and nitroprusside infusion is given as a no-donor.Pressure drop decreases gradually and at the end of the perfusion measures 17mmhg/l (flow rate 5.5l/min).The patient bleeds diffuse and from the nasopharynx.Considering suspected thrombocyte consumption platelet" (b)(4).

Manufacturer Narrative

The product was discarded by the hospital and was unavailable for return.Therefore, a full investigation could not be performed.A clinical assessment was performed and it was concluded that from the reported information there is no indication that the device malfunction was caused by an application error, however, the root cause cannot be determined.A dhr review was performed based on the available information.The dhr of the affected packaging lot was inspected and (b)(4) units of quadrox i-adult hmo 70000 have been manufactured from 2016-04-22 until 2016-05-04 with no abnormalities or nonconformities found.No systemic issue was identified from the complaint database review but the data, however, will continue to be monitored and 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 investigation or action is warranted at this time and the complaint will be closed.Please note this is the final report.

Event Description

(b)(4).

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• 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 ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 6456590
• MDR Text Key: 71907561
• Report Number: 8010762-2017-00112
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K082117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2018
• Device Model Number: HQV 101700
• Device Catalogue Number: 701064900
• Device Lot Number: 92188468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2017
• Date Device Manufactured: 05/01/2016
• 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