MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the hospital: "there is blood leakage from the one-way valve connection during patient use." (b)(4).

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).Rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).Importer- maquet medical systems usa (b)(4).Contact person- (b)(6).Since the failure is known, the product was not needed for investigation in the laboratory of manufacturer.The article and lot numbers of the finished product was not available.Therefore trend search was performed based on similar incidents.Trend search shows additionally 22 complaints which appears reported issues are the same since the last 12 months however recorded with different material numbers and failure codes.Also a meaningful device history record review could not be performed.Dhr of semi-finished hahnenbanklinie line could be reviewed only.No abnormality was found.Getinge cp antalya has been initiated a capa, based on several complaints showing the same symptoms with different material numbers than the one in this complaint, in order to determine the root cause and initiate further actions to determine corrective measures for the failure.All further steps will be performed in accordance to capa 2015/03.This complained product was manufactured before the corrective actions are implemented in capa(b)(4).As a corrective action, capa (b)(4) has been already initiated to address the appropriate corrective/preventive actions.The adapter with the article number(b)(4).Is already involved in capa(b)(4).A new material/reducer was supplied and the new material will be used instead of this adapter in the scope of capa (b)(4).The red tube will be assembled with the reducer to solve the problem.Ecr (b)(4).Was initiated for this change.The data is being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

Event Description

Ref.: #(b)(4) customer ref.: #(b)(4).

• Brand Name: RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7233530
• MDR Text Key: 99088275
• Report Number: 8010762-2018-00041
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• PMA/PMN Number: K090534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2018
• Initial Date FDA Received: 02/01/2018
• Supplement Dates Manufacturer Received: 05/14/2018
• Supplement Dates FDA Received: 05/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1