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

Model Number VKMO 11000

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/18/2018

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (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 ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002 importer- (b)(4).

Event Description

Ref.: #(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).Investigation was performed based on similar complaint(b)(4).It can be clearly seen that there is a leakage between the 70104.5749 tube and 70105.2890 adapter tube.Based on this failure could be confirmed.Sap trend search was performed (material 70104.9279, failure code 0122 tubing set connection) which came to following results:0 additional complaints were recorded since the last 12 months.Based on the sales figures of the last 12 months following occurrence rate has been calculated: (b)(4) , which is below than 1%.Due to this information no systemic issue could be determined.Also maquet cardiopulmonary is aware of similar issues which were recorded with different material numbers and failure codes.Therefore 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 2015/03.Device history record was reviewed.There were no references found which are indicating a nonconformance of the product in question.As a corrective action, capa (b)(4) has been already initiated to address the appropriate corrective/preventive actions.The data is also 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: 7264865
• MDR Text Key: 99997904
• Report Number: 8010762-2018-00050
• 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,Followup
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2019
• Device Model Number: VKMO 11000
• Device Catalogue Number: 701049279
• Device Lot Number: 92232921
• Date Manufacturer Received: 07/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1