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

Model Number HMO 50000-J

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913); Pressure Problem (3012)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888)

Event Date 08/14/2017

Event Type  Death  

Manufacturer Narrative

Maquet medical systems, usa 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.

Event Description

According to the customer: "there was heavy bleeding during the cardiovascular surgery (case: right side of renal cancer, method: right radical nephrectomy (transthoracic and transabdominal approach), ivc ~ right atrium tumour embolus extirpation).Then, the customer started using the extracorporeal circulation circuit and controlling the condition of the patient.3 hours after the pump started, the co2 removal and the oxygenation decreased in performance drastically.It was observed that bubbles (just like plasma leak) were leaking from the membrane of the oxygenator.There was no pressure increase at the inlet and outlet of the oxygenator.The patient expired after the surgery due to bleeding.The customer considers that there is no causal connection between the incident and the patient's death." (b)(4).Also referencing to record (b)(4) for the gas.

Manufacturer Narrative

The product was investigated at the laboratory of the manufacturer.Hereby a leakage from the gas outlet port was confirmed.Affected product: basic lot 70116605 and packaging lot 70116606 (serial number (b)(4)).The avz from (b)(4) was reviewed on 2017-10-13.There were no references found, which are indicating a nonconformance of the product.The reported failure is known and was investigated within capa (b)(4) with the following outcome:the described defect of leaking oxygenators is covered by the risk assessment and control and with the implementation of the spc at the receiving inspection classified "as low as reasonable possible".The effect of cold creeping is not predictable and not reproducible.From an engineering point of view no changes of production processes or further controls are technically feasible to reduce or avoid cold creeping.Based on these investigation results no additional preventive measures can be taken at this point.Due to the fact that the defect leaking oxygenator caused by cold creeping is neither reproducible nor predictable and from the engineering point no improvements technically feasible the capa- (b)(4) will be transferred into track and trending process.

Event Description

(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: 6859004
• MDR Text Key: 85809574
• Report Number: 8010762-2017-00294
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K090689
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/24/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2019
• Device Model Number: HMO 50000-J
• Device Catalogue Number: 701048781
• Device Lot Number: 70116606
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2017
• Initial Date FDA Received: 09/12/2017
• Supplement Dates Manufacturer Received: 10/20/2017
• Supplement Dates FDA Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• 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