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

Model Number BE-HLS 7050 USA

Device Problems Device Operates Differently Than Expected (2913); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2016

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2016 12:12 pm (gmt-4:00) added by (b)(6) ((b)(4)): (b)(4).The product was requested for investigation but has not been returned.The investigation is pending.A supplemental medwatch will be submitted when further information becomes available.Additional information: the product mentioned 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

On (b)(6) 2016 12:07 pm (gmt-4:00) added by (b)(6) ((b)(4)): no reported patient effect.On (b)(6) 2016 12:02 pm (gmt-4:00) added by (b)(6) ((b)(4)): according to the customer: pressures being displayed were out of range.Delta p was dashed out.(b)(4).

Manufacturer Narrative

The product was investigated in the laboratory of the manufacturer.The connectors and plugs of the product were sealed before cleaning in order to protect them from humidity.Afterwards the product was visually inspected with the following results: a crack at the luer lock of the blood outlet connector was detected (an additional complaint will be opened in order to track and trend this failure).The contact pins of the sensors plug were corroded.The solder joints of the delta p sensor were corroded and polluted with blood.The blood was removed from the sensor and the contacts were dried.The product was also connected to the cardiohelp, a circuit was created on the blood side.All pressures were displayed at the display.No additional abnormalities were found.Most probable pollution of the contact pins, sensors plug and delta p sensor were leading to the reported failure.The investigation is still ongoing.This failure was determined to be the first of it's kind (due to this information no systemic issue could be determined)and is being handled through a designated maquet cardiopulmonary trending process.If a trend occurs, it will be escalated to quality assurance management for review and determination of applicable investigation.Due to this no further action will be completed at this time.

Event Description

(b)(4).

Manufacturer Narrative

The product was tested for it's o2-, co2 transfer rate and for its pressure drop behavior at maximum blood flow.No abnormalities were detected, the product passed all test steps and was operating within specifications.Due to this a confirmation of the failure "pressures being displayed were way out of range" & "delta p dashed out" is not possible.Based on these results and the information available at this time, the oxygenator in question operated within maquet cardiopulmonary specifications.This is the final report.

Event Description

(b)(4).

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: TUBING, PUMP, 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: 5498685
• MDR Text Key: 40576702
• Report Number: 8010762-2016-00175
• Device Sequence Number: 1
• Product Code: DWE
• 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,Followup
• Report Date: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-HLS 7050 USA
• Device Catalogue Number: 70105.2789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1