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

Model Number 70104.3262

Device Problems Out-Of-Box Failure (2311); Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 08/15/2013

Event Type  malfunction  

Event Description

On (b)(6) 2013 at the (b)(6) center it was reported that the dpm 20-440 dual pressure module serial number unknown used with the hl 20 5 pumps console base serial number (b)(4) did not detect channel 2 pressure.This is an out of box failure/no patient involvement.(b)(4).

Manufacturer Narrative

Maquet medical system, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).The dpm was investigated at the ssu and a loose pin was found in the channel 2 transducer socket.The loose pin was placed back into the socket and secured using a nylon locking cable tie.The issue was resolved.(b)(4).

• Brand Name: HL-20 INTEGRATED PERFUSION SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• 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: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4944655
• MDR Text Key: 6256263
• Report Number: 8010762-2014-00897
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/15/2013

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: 70104.3262
• Device Catalogue Number: MCP00706195
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/15/2013
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2013
• Initial Date Manufacturer Received: 08/15/2013
• Initial Date FDA Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1