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

Model Number HMO 71000-J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Test Result (2695); No Code Available (3191)

Event Date 10/26/2015

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2015 10:13 am (gmt-5:00) added by (b)(6) ((b)(4)): (b)(4).Investigation of the device is not complete.A supplemental medwatch will be submitted when additional information becomes available.

Event Description

"during the use of hmo71000 (vr is rr40 from terumo) for mvp case, the patient's blood platelet level decreased rapidly.The customer requested to provide us the snap photo shot investigated by magnifying scope (or sem), in which the platelet was absorbed on the filter area of oxygenator.The number of blood platelet: before the pump initiation - approx.150,000, during pumping - approx.80,000, just before getting off the pump - 30,000.At the end, gave a platelet transfusion and the surgery was finished.(pumping time 110 min.) no pressure increase of the oxygenator during the pump was found, there seems not to be occluded.No adverse effects on the patient.(b)(4).

Manufacturer Narrative

(b)(4).The product was visually inspected in the laboratory of the manufacturer with no abnormalities found.No additional test methods which could provide explicit results regarding the coating could be used as every oxygenator runs through a cleaning step with sodium hypochlorite during receipt process within the decontamination laboratory.The sodium hypochlorite could have an influence on the coating or at the least is changing the primitive state of the coating.Based on this the test results would not be valid.No issues were noted in the device history record for the coating process.The cause of the failure was determined to not be attributed to a device related malfunction.Based on these results and the information available at this time, the oxygenator operated within maquet cardiopulmonary specifications.This data will be handled through a designated maquet trending process.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 action will be completed at this time.

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 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; 4972229321
• MDR Report Key: 5233116
• MDR Text Key: 31503683
• Report Number: 8010762-2015-01179
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2017
• Device Model Number: HMO 71000-J
• Device Catalogue Number: 70104.8762
• Device Lot Number: 70104731
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2016
• Date Device Manufactured: 05/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention