MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number HQV 44202

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 07/24/2017

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).The device was requested but not yet received.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

After 80 minutes on cardiopulmonary bypass the perfusionist noticed a small amount of blood was leaking out of the dia connector on the arterial side of the integrated filter.The blood leakage was not deemed necessary to swap out the device and the case ended uneventfully." (b)(4).

Manufacturer Narrative

(b)(4).The product was investigated in the lab of the manufacturer.A tightness test was performed.And additionally leak between o-ring and lock pin was detected.A small offset in the filter cover, in the seat of the o-ring (sealing area) and an impression with plasticine of the filter cover was observed.No further abnormalities noted.Based on this leakage at the dia connector can be confirmed.A sap trend search was performed for p/n 70107.0151 failure code 0104 dialysis lock and valve and no similar complaint was found for this type of material.Besides that mcp has decided, based on several complaints for the dialysis lock and valve showing the same symptoms with different material numbers than the one in this complaint, to initiate another capa in order to determine the root cause and initiate further actions to determine corrective measures for the failure as well as to clarify whether a systemic issue is present.All further steps will be performed in accordance to capa (b)(4).

Event Description

(b)(4).

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 6770138
• MDR Text Key: 82141330
• Report Number: 8010762-2017-00259
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K082117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2019
• Device Model Number: HQV 44202
• Device Catalogue Number: 701070151
• Device Lot Number: 92212053
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2017
• Date Device Manufactured: 01/01/2017
• 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