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

Model Number BEQ-HLS 7050 USA

Device Problem Device Operates Differently Than Expected (2913)

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

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 was 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 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 4th circuit.70110362 is first circuit.(complaint # (b)(4)) 70110996 is second circuit (complaint # (b)(4)) 70110996 (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 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.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: 5840259
• MDR Text Key: 52122322
• Report Number: 8010762-2016-00495
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HLS 7050 USA
• Device Catalogue Number: 701052794
• Device Lot Number: 70110996
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2016
• Initial Date FDA Received: 08/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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