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

Model Number VKMO 11000

Device Problems Insufficient Flow or Under Infusion (2182); Device Operates Differently Than Expected (2913)

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

Event Date 04/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).(b)(6).

Event Description

According to the report from the customer: "in patient warm-up, even with an increase in the supply of o2 that is normal during this phase of the procedure (placed at 70%) and the mechanical ventilation of the patient started by the anesthesiologist, the patient's po2 result was very low for the parameters that were being used (72.8mmhg).The product was replaced to continue the procedure." (b)(4).

Manufacturer Narrative

Maquet medical systems, usa (importer) submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption#: (b)(4).Importer: (b)(4).Contact person: (b)(6).A quadrox-i neonatal with reservoir was returned.The sample was investigated visually.No further abnormalities were detected.A further investigation is currently not possible for safety reasons.Thus the reported failure could not be confirmed.Sap trend search was performed (search for material 70104.9279 and similar failure) which came to following result: 1 additional complaint was recorded since the last 12 months.Based on the sales figures of the last 12 months following occurrence rate has been calculated: (b)(4), which is below (b)(4).Due to this information no systemic issue could be determined.Affected product: basic lot: 70119892 and packaging lot: 70119894 (serial number: (b)(4).The avz from (b)(4) and (dms#: 2511382) was reviewed.There was no reference found, which is indicating a nonconformance of the product in question.Further investigation steps are momentarily not possible to be executed due to work safety issues in the complaint laboratory.Maquet cardiopulmonary is currently in the mitigation of this issue.When further investigation steps can be executed again, these investigations will be performed and the complaint file will be updated accordingly.Thus the most probable cause of the reported event remains unclear at this time.The data is 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

Ref#: (b)(4).(b)(6).

Manufacturer Narrative

Maquet medical systems,usa (importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.Importer- maquet medical systems usa, 45 barbour pond drive, wayne, nj 07470.Contact person- (b)(4).

Event Description

(b)(4).

Manufacturer Narrative

The lot # and expiration date corrected in section d maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).Rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).Importer- maquet medical systems usa (b)(4).Contact person- (b)(6).

Event Description

Ref.: #(b)(4).Customer ref(b)(4).

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7549437
• MDR Text Key: 109623009
• Report Number: 8010762-2018-00189
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K102464
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: VKMO 11000
• Device Catalogue Number: 701049279
• Device Lot Number: 92232742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Initial Date Manufacturer Received: 05/04/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 05/29/2018; 05/29/2018; 05/29/2018
• Supplement Dates FDA Received: 06/04/2018; 08/07/2018; 08/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1