MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HC 2821-J#KARDIOTOMIERESERVOIR

Model Number 70103.1718

Device Problems Break (1069); Crack (1135)

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

Event Date 04/13/2015

Event Type  malfunction  

Event Description

It was reported that: "when the user tried to connect the extracorporeal blood circuit of heart-lung machine to the reservoir, the two sucker connectors (blue ports) of the reservoir were broken.So the user re-connected the blood circuit to the unfiltered connectors (on the top of the main body) of the reservoir.The surgery operation was not affected by this incident".(b)(4).

Manufacturer Narrative

A f/u medwatch will be send after receiving further info.

Manufacturer Narrative

Sample has been discarded by the hospital, therefore no investigation on the sample is possible.Visual inspection has been performed on the pictures sent along with the complaint.Thus failure could be confirmed.Dhr-review of 70103.1718, lot: 70095057 shows no abnormalities.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: HC 2821-J#KARDIOTOMIERESERVOIR
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4745311
• MDR Text Key: 16467295
• Report Number: 8010762-2015-00421
• Device Sequence Number: 1
• Product Code: DTN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor,company rep
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70103.1718
• Device Catalogue Number: HC 2821-J
• Device Lot Number: 70095057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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