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

Model Number 70105.2794

Device Problem No Device Output (1435)

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

Event Date 08/22/2015

Event Type  Injury  

Manufacturer Narrative

September 17, 2015 10:10 am (gmt-4:00) added by (b)(6): (b)(4).The device has been requested but not yet received.A supplemental medwatch will be submitted when additional information becomes available.(b)(4).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

It was reported that during initiation of the room the cardihelp pressure transducer function failed to work appropriately.Attempts to re-zero and a console exchange did not solve the problem.It was determined that the disposable (pressure strip) was not working.The patient was not stable enough at the time to undergo a circuit changeout.There was a non-sterile disposable connected to the pressure cable to prevent continuous alarming.The saturation/hb probe was fully functioning.The device was not replaced and therapy was eventually discontinued.No reported patient effect or delay in therapy was reported.(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): MICHAEL CAMPBELL; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437
• MDR Report Key: 5086776
• MDR Text Key: 26162976
• Report Number: 8010762-2015-01050
• 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
• Report Date: 08/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70105.2794
• Device Catalogue Number: BEQ-HLS 7050 USA
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/23/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2015
• Date Manufacturer Received: 08/23/2015
• 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): Required Intervention