MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HL-20 INTEGRATED PERFUSION SYSTEM; CONSOLE, HEART/LUNG MACHINE

Model Number MCP00702625

Device Problem Sensing Intermittently (1558)

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

Event Date 09/28/2011

Event Type  Injury  

Event Description

On (b)(6) 2011, (b)(6) hospital contacted the maquet service representative concerning issues with the bubble sensor on the hl-20 mlc 20-152 / mid left oriented console, 5-pumps (article number: mcp0.0702625, serial number: (b)(6)).The perfusionist stated that the bubble sensor was defective and had been replaced - the defective sensor was discarded.Another perfusionist then observed similar problems with the new bubble sensor, involving intermittent operation of the sensor.The sensor was removed and replaced with one from a different unit and this one functioned correctly.An additional mdr was generated for the first event.The second mdr # is 8010762-2014-00517.(b)(4).

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary (b)(4) provides product failure investigation, analysis, and resolution for the device described in this report.The maquet service technician inspected the bubble sensors with a perfusionist and have tired various corrections to correct the intermittent operation.These attempts have not been successful.The original bubble sensor in which this problem was observed was discarded and unavailable.None of the bubble sensors were returned to the manufacturer.(b)(4).

• Brand Name: HL-20 INTEGRATED PERFUSION SYSTEM
• Type of Device: CONSOLE, HEART/LUNG MACHINE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer Contact: kehler strasse 31; rastatt, 76437
• MDR Report Key: 4283295
• MDR Text Key: 5226594
• Report Number: 8010762-2014-01079
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/29/2011,09/28/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00702625
• Device Catalogue Number: MCP0.0702625
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2011
• Date Manufacturer Received: 09/29/2011
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention