MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET W/BIOLINE COATING; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number BE-PLS 2050

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/08/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During priming, a black particle was found on the outlet side of the oxygenator.For that reason, this product couldn¿t be used.(b)(4).

Manufacturer Narrative

The product was investigated in the laboratory of the manufacturer.A grey foreign matter was detected on the blood inlet side beneath the de-airing membrane.In order to identify the particle the oxygenator was sawed and the foreign matter was separated.The particle was grey and rubber-like.The dimensions are: length 3,64 mm, width 1,61 mm.The source and the identity of the particle is unknown.Based on this the failure "foreign matter on upper venous side" could be confirmed.Trend search: a sap trend search was performed for p/n 70102.7818, failure code 0719 foreign matter and no additional complaint was found.Due to this information no systemic issue could be determined.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

(b)(4).

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: TUBING, PUMP, 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: 6000919
• MDR Text Key: 57115485
• Report Number: 8010762-2016-00609
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K080592
• 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: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-PLS 2050
• Device Catalogue Number: 701027818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2017
• 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