MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG NEW BC 20 PLUS-J#HEMOCONCENTRATOR BC 20

Model Number NEW BC 20

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 04/23/2015

Event Type  Injury  

Event Description

It was reported that the customer detected a blood leakage from the outlet side of the bc soon after circulation.The prod was replaced.(b)(4).

Manufacturer Narrative

The device was requested for investigation but it hasn't arrive yet.A supplemental medwatch will be submitted when add'l info becomes available.

Manufacturer Narrative

The device was returned to the supplier of maquet and was investigated.Torn fibers could be detected.High flow and/or pressure during preparation and use of product may have cause this kind of failure.The device history record was checked but no conspicuity could be found for this lot number.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation limitations will be completed at this time.

Event Description

(b)(4).

• Brand Name: NEW BC 20 PLUS-J#HEMOCONCENTRATOR BC 20
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strabe 31; rastatt 76437 ; GM 76437
• MDR Report Key: 4764824
• MDR Text Key: 5776729
• Report Number: 8010762-2015-00434
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123288
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Model Number: NEW BC 20
• Device Catalogue Number: 70106.3528
• Device Lot Number: 92149382
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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