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

Model Number VKMO 71000

Device Problem Gas/Air Leak (2946)

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

Event Date 09/24/2018

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation yet.Maquet cardiopulmonary gmbh will submit a supplemental medwatch on receipt of further information.The case was reported to the ministry of health(moh) on (b)(6) 2018.(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

According to the hospital: "more leakage of air was seen during priming at the junction of the arterial filter to membrane of the oxygenators".(b)(4).

Event Description

Ref.: #(b)(4)., customer ref(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).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).Maquet cardiopulmonary gmbh was investigated the products in the complaint laboratory.No faults were found in the visual inspection of two complaint samples.Also in the leak test according to lv 201 and in the simulated priming process with water, no deficiencies were found.The deficiencies claimed by the customer could not be observed in our investigations and therefore not confirmed.The problem is not reproducible.Sap trend search was performed (component quadrox, failure code 0311/1016 air in the system) which came to following results: 7 additional complaints were recorded which appears reported issues are the same since the last 12 months.Based on the sales figures of the last 12 months following occurrence rate has been calculated: 0,12%, which is below 1%.Due to this information no systemic issue could be determined.Device history records were reviewed.There were no references found, which are indicating a non-conformance of the product in question.The reported failure did not contribute to death or serious injury.In addition it cannot be concluded at this time that this is systemic error.No corrective action is needed.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.

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7965302
• MDR Text Key: 126092525
• Report Number: 8010762-2018-00277
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/13/2018

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: 06/08/2019
• Device Model Number: VKMO 71000
• Device Catalogue Number: 701063877
• Device Lot Number: 92226369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Initial Date Manufacturer Received: 10/06/2018
• Initial Date FDA Received: 10/15/2018
• Supplement Dates Manufacturer Received: 12/06/2018
• Supplement Dates FDA Received: 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1