MAUDE Adverse Event Report: BERND RAKOW RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Model Number VKMO 11000

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 12/19/2017

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: "during use of the device, a leakage was observed at the one-way valve of the sampling line." (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- (b)(4).Contact person- (b)(6).Sap trend search was performed (material 70104.9279, failure code 0128 manifold) which came to following results: 6 additional complaints were recorded which appears 5 reported issues are the same since the last 12 months.Maquet cardiopulmonary gmbh is aware of similar incidents with different material numbers and failure codes both on sap and tw.Based on the sales figures of the last 12 months following occurrence rate has been calculated: 0,1%, which is below 1%.Due to this information no systemic issue could be determined.The picture of the defect product shows clearly the leakage between tubes 70104.5749 and 70105.2890.Based on this the failure could be confirmed.Besides that 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 capa2015/03.As a corrective action, capa 2015/03 has been already initiated to address the appropriate corrective/preventive actions.The adapter with the article number 70105.2890 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 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.Device history record was reviewed.There were no references found which are indicating a non-conformance of the product in question.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): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• MDR Report Key: 7171656
• MDR Text Key: 96832219
• Report Number: 8010762-2018-00003
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• PMA/PMN Number: K141432
• 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: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2019
• Device Model Number: VKMO 11000
• Device Catalogue Number: 701049279
• Device Lot Number: 92228010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1