MAUDE Adverse Event Report: MAQUET CARDIOPULMOARY AG MAQUET HL-20 TWIN PUMP; FLOWMETER, BLOOD, CARDIOVASCULAR

Model Number MCP00703277

Device Problems Pumping Stopped (1503); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 08/18/2011

Event Type  malfunction  

Event Description

On (b)(6) 2011, at (b)(6), an "arterial stop" error was received on twin pump module (tpm) en med c (article number: (b)(4)) while being used with hl20 5 pump console ((b)(4)) the arterial pump works properly (e.G.100 rotations/min), however, the cardioplegia pump (in slave mode) turns a quarter of turn, then stops, then turns a half a turn, then stops, and so on.This problem was observed after the field service engineer performed a software update on the tpm from version 1.4 to new software version 2.5.A second mdr will be generated for this event since two twin pump module and console serial numbers are listed in the complaint.The second mdr # is 8010762-2014-01077.(b)(4).

Manufacturer Narrative

(b)(4).The field safety engineer (fse) performed the update mcv/011/0002/iu on 2 tpms.The fse updated software version 1.4 to version 2.5.Based upon communication with the service department, the version 2.5 software was only for release 11 tpms, the tpms involved in this event were release 10.The fse was instructed to reinstall the old, version 1.4 software on the tpms.(b)(4).

• Brand Name: MAQUET HL-20 TWIN PUMP
• Type of Device: FLOWMETER, BLOOD, CARDIOVASCULAR
• Manufacturer (Section D): MAQUET CARDIOPULMOARY AG; kehler strasse 31; rastatt, 76437 ; 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: 4280410
• MDR Text Key: 21329248
• Report Number: 8010762-2014-00504
• Device Sequence Number: 1
• Product Code: DPW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: 984338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/02/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00703277
• Device Catalogue Number: MCP0.0703277
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/02/2011
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2011
• Date Manufacturer Received: 09/02/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2004
• 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