MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG PATIENT HAS AUTOIMMUNE ANEMIA; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number PATIENT HAS AUTOIMMUNE ANEMIA

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product which was complained under complaint # (b)(4) is not available for investigation.Therefore maquet cardiopulmonary (b)(4) requested the product which was used as third circuit (set lot # 70110996 ; oxy lot # 70108712) for manufacturers laboratory investigation.A review for similar complaints for the specific product has been performed and no similar incident with a failure confirmed was found.Based on this, we will refer to investigation of complaint # (b)(4).Investigation is still pending.A supplemental medwatch will be submitted as soon as further information becomes available.(b)(4) additional information: the product mentioned under section d is a tubing set and the included affected component has the contributing design function of the quadrox-id which is registered under 510(k): k101153.

Event Description

Description from the customer report: "patient pao2 drops after about 7 days of use.This has been the case on the same patient and the clinicians are changing to their 3rd circuit.The 70110362 is first circuit.(complaint (b)(4)).The 70110996 is second circuit (complaint # (b)(4)).The 70110996 (oxy lot # 70108712) is 3rd circuit (and is the one being returned ; complaint # (b)(4)).The 4th circuit has no reported issues.Additional info: patient has autoimmune anemia.Propofol is occasionally used for anesthesia.Oxy udi's are not recorded, only lot numbers by the customer.No patient consequences were described".(b)(4).

Manufacturer Narrative

The product in question was not available for return; therefore a laboratory investigation of the manufacturer was not possible.The incident report says that 3 oxygenators were exchanged for the same patient.One of the exchanged oxygenators was returned under record id (b)(4) and was investigated as follows.The product was tested for its o2, co2 transfer rate and pressure drop behavior at maximum flow and passed all test steps successfully.No abnormalities were detected.Based on this the reported failure "pao2 drops" could not be confirmed.The cause of this failure was determined to not be attributed to a device related malfunction.The most probable cause of the incident is unknown.Based on the above mentioned investigation results the failure reported within this incident report could not be confirmed.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a 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.

Event Description

(b)(4).

• Brand Name: PATIENT HAS AUTOIMMUNE ANEMIA
• 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: 5840567
• MDR Text Key: 52292860
• Report Number: 8010762-2016-00497
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2018
• Device Model Number: PATIENT HAS AUTOIMMUNE ANEMIA
• Device Catalogue Number: 70105.2794
• Device Lot Number: 70110996
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2016
• Date Device Manufactured: 04/01/2016
• 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