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

Model Number MCP00706195

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 02/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Field safety technician has been sent for investigation and found that level detection and override function level failed.According to service protocol, dated on (b)(6) 2017, the cls level sensor (s/n (b)(4)) has been replaced.The defective cls has been requested by the manufacturer for further investigation.A supplemental medwatch will be submitted after new information has been received.

Event Description

It was reported that a defective capacitive level sensor on a hl20 - level detection and override function level failed.Failed.No patient was involved.(b)(4).

Manufacturer Narrative

The defective capacity level sensor has been requested for investigation by (b)(4).According to service report by (b)(4): the failure could be reproduced.The sensor provides an output of up to 4.5v for the 6mm-makrolon-wall of the test-reservoir.The test-reservoir is completely filled with water.Under this conditions, this is not as specified - as the voltage output may not be higher.No visible external damage, also the connection cable shows no electrical as well as mechanically abnormalities.The operating point of the cls, which was initially set, has changed.In consultation with the customer, the sensor is retained by (b)(4) and replaced free of charge, since a further troubleshooting can only be carried out by destroying the sensor.The failure could be confirmed.Furthermore the device history record of the 70104.3262 mcp00706195#vario twin, hl 20, 4-pumps, serial# (b)(4) has been reviewed:there were no references found, which are indicating a nonconformance of the product in question.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.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.

Event Description

(b)(4).

• Brand Name: HL-20 INTEGRATED PERFUSION SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, 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: 6391363
• MDR Text Key: 69810724
• Report Number: 8010762-2017-00076
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2017

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: MCP00706195
• Device Catalogue Number: 701043262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2017
• Initial Date FDA Received: 03/09/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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