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

Model Number HMOD 70000-USA

Device Problems Device Operates Differently Than Expected (2913); Filtration Problem (2941)

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

Event Date 10/20/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been requested for return; but not yet received.A supplemental medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

Trans-membrane pressures started to rise drastically from 20 to approx.100.Product was replaced with no incident.(b)(4).

Manufacturer Narrative

(b)(4).The product was visual inspected in the laboratory of the manufacturer.The oxygenator was rinsed with water once and was nearly clean except for one clot on the blood outlet side.No other abnormalities were found.The product was forwarded to the qa laboratory for a performance test.The product was tested for its o2 and co2 and pressure drop performance according to lv 009.The product passed the acceptance criteria's and operated according to the specifications, no abnormalities were found.This data will be handled through a designated maquet trending process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further action will be completed at this time.A supplemental medwatch will be submitted when further information becomes available.

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): MICHAEL CAMPBELL; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437
• MDR Report Key: 5215375
• MDR Text Key: 30966366
• Report Number: 8010762-2015-01158
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K100278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2017
• Device Model Number: HMOD 70000-USA
• Device Catalogue Number: 70105.3815
• Device Lot Number: 70106463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/20/2015
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2015
• Date Manufacturer Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 14 DA