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

Model Number BE-PLS 2050

Device Problem Shelf Life Exceeded (1567)

Patient Problem Death (1802)

Event Date 12/04/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary (b)(4) requested the product back for investigation but has not received it until yet.The manufacturer will not be able to investigate the outer package as it has already been discarded by the hospital.Furthermore no photo could be provided from the outer package where the expiry date "2016" was stated.A device history record was performed by the manufacturer.It confirms that there is no scrap record or any rework record for this lot.Also, during the dhr review, the labels were checked, there are no anomalies whatsoever.The labels indicate the expiry date as ¿2014-03¿.Also, a complaint statistic review was performed, which also indicates that there is no other customer complaint associated with this particular lot.Furthermore it was checked that 91 sets of lot # 70074993 have been shipped to the customer in may 2012.Investigation is still pending.A supplemental medwatch will be submitted as soon as further information becomes available.

Event Description

Description from the customer report: "the expiry date on the outer package is in the year 2016, so they just used it on the patient.And then they found the expiry date on the inner package is in the year 2014.However, the patient could not survive without ecmo, so the relatives decided to stop the support.The patient died." (b)(4).

Manufacturer Narrative

(b)(4).

Event Description

(b)(4).Additional information received february 1, 2016: the patient death was not related to the maquet product.(b)(4).

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• 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 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; 4972229321
• MDR Report Key: 5317680
• MDR Text Key: 34086076
• Report Number: 8010762-2015-01274
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K080592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2014
• Device Model Number: BE-PLS 2050
• Device Catalogue Number: 70102.7818
• Device Lot Number: 70074993
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/19/2016
• Date Device Manufactured: 03/01/2012
• 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): Death