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

Model Number VKMO 78000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Cardiac Enzyme Elevation (1838)

Event Type  Death  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the hospital: "during operation of a patient; decrease in albumin levels, increase in both urea creatinine and liver enzyme level had been occurred.The patient had died on unknown dates in post-op period.Due to the event, the hospital does not want to use the batches.There is no absolute doubt on the product in relation with death.It has been reported that an investigation done for all the products used in the operations." (b)(4).

Manufacturer Narrative

The available information has been shared internally with the getinge (b)(6).It was stated that with the data provided in the case, it is impossible to find out any relationship between the device and the reported event.There is no direct association between increased renal and liver parameter and use of the devices in the case.The investigation report does not show abnormalities either.Due to the limited information available, a more comprehensive and detailed clinical assessment is not possible.A dhr review was performed based on the available information.The dhr of the affected lot 70107389 and packaging lot 70108586 (serial number (b)(4)) was inspected.The (b)(4) was reviewed.There were no references found, which are indicating a nonconformance of the product.The reported set was discarded by the hospital.However, the set(after priming process) was sent as a complaint sample which has not been used with any patient.Laboratory investigation results are still pending.Maquet cardiopulmonary (b)(4) will submit a supplemental medwatch on receipt of further information.

Event Description

(b)(4).

Manufacturer Narrative

The claimed set was thrown away by the hospital.However, the set (after priming process) was sent as a complaint sample which has not been used with any patient.The set was examined visually by our laboratory.The oxygenator was rinsed with water and no abnormalities detected.The product was forwarded to the qa lab for further testing.In the qa laboratory, the product was tested for its gas exchange performance for o2 and co2, and also a pressure drop test was performed.The product passed all the performance tests and found to be working as specified.A sap trend search has been performed (search for material (b)(4)), which came to following results:no additional complaints were recorded.Based on the trending, a systemic issue is not indicated.The most probable cause of the failure is unknown at this time.According to the information available at this time, a malfunction of the product cannot be confirmed.Based on the investigation and trending for this issue, neither a product malfunction nor a systemic issue is indicated, therefore no further investigation or action is currently warranted in addition to continued periodic monitoring, and the complaint will be closed.This data will be handled through a designated maquet trending process.If at 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.

Event Description

Ref.: #(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: 6409622
• MDR Text Key: 70105598
• Report Number: 8010762-2017-00085
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K082117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2017
• Device Model Number: VKMO 78000
• Device Catalogue Number: 701067941
• Device Lot Number: 92178828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• 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): Death