MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET W/BIOLINE COATING; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HLS 5050 USA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet (b)(4).The device has been requested but not yet received.A follow-up medwatch will be submitted if additional information becomes available.Additional information: the product mentioned under section is a tubing set and the included affected component has the contributing design function of the quadrox-id small adult which is registered under 510(k): k132829.

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 2nd circuit.(b)(4) is first circuit.(complaint # (b)(4)) (b)(4) is second circuit (complaint # (b)(4)) (b)(4) (oxy lot # 70108712) is 3rd circuit (and is the one being returned ; complaint # (b)(4)) 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 was not available to return; therefore a manufacturer laboratory investigation 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 of a device with contributing design function 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: HLM TUBING SET W/BIOLINE COATING
• 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: 5840271
• MDR Text Key: 52286677
• Report Number: 8010762-2016-00496
• 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: 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: 02/01/2018
• Device Model Number: BEQ-HLS 5050 USA
• Device Catalogue Number: 70105.2797
• Device Lot Number: 70110362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2016
• Date Device Manufactured: 02/01/2016
• 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