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

Model Number BO-VKMO 71000

Device Problems Insufficient Cooling (1130); Insufficient Heating (1287); Infusion or Flow Problem (2964)

Patient Problem Alteration In Body Temperature (2682)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the customer:'after the extracorporeal circulation was started, the customer noticed that cooling patient was taking time than usual.The customer was initially supposing it was because of the patient with kidney failure.Then, it was observed that the temperature didn't go up during re-warming and the flow volume for the heat exchanger was not sufficient.They replaced the heater-cooler unit, however the flow volume was still not enough.The customer weaned the patient at the temperature of 33°c as it was unable to complete re-warming.No adverse effects on the patient.The product will be delivered to mcp.(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 recieved the product back for investigation.A quadrox-i adult was sent back.The pattern was contaminated.Sample cleaned with sodium hypochlorite.When rinsing the water side no particles were rinsed out.No further abnormalities could be detected.Error could not be confirmed.The failure is defined as not comprehensible and not reproducible.Device history record was reviewed.There were no references found, which are indicating a nonconformance of the product in question.A sap trend search was performed (component 70106.7793, failure code 0302 heat exchanger/bad performance) and no additional complaint was 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: 0,024%, which is below 1%.Due to this information no systemic issue could be determined.The reported failure did not contribute to death or serious injury.In addition at this time it cannot be concluded that this is a systemic error.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: 7569210
• MDR Text Key: 110343970
• Report Number: 8010762-2018-00202
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K082117
• 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: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2019
• Device Model Number: BO-VKMO 71000
• Device Catalogue Number: 701067951
• Device Lot Number: 92230626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Date Manufacturer Received: 10/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1