MAUDE Adverse Event Report: MAQUET CARDIOPULMOARY AG TUBING PACKS WITH BIOLINE COATING; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number BE-HQV 34601

Device Problem Occlusion Within Device (1423)

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

Event Date 09/05/2011

Event Type  malfunction  

Event Description

On (b)(6) 2011, (b)(6) center (b)(6), reported that for the tubing pack be-hqv 34601 (article number: 70103.3326, serial number: (b)(4)) the suction valve was occluded, while the pressure relief valve does open.However the one-way valve stays closed and does not suck up any blood.Reference: (b)(4).

Manufacturer Narrative

(b)(4).The tubing set was returned for investigation.The occlusion of the valve was verified.The device was sent to the supplier for addition investigation.The cause was a manufacturing problem.The valve inside the unit became fused together during the manufacturing process.As a corrective action the supplier implemented monitoring equipment to reduce fused valves.As a preventive action a visual 100% control of the valves was established.Reference: (b)(4).

• Brand Name: TUBING PACKS WITH BIOLINE COATING
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMOARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer (Section G): MAQUET CARDIOPULMOARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4278466
• MDR Text Key: 5005723
• Report Number: 8010762-2014-00366
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K080592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/05/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-HQV 34601
• Device Catalogue Number: 70103.3326
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/05/2011
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2011
• Date Manufacturer Received: 09/05/2011
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2011
• 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