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

Model Number MCP00703323

Device Problems Out-Of-Box Failure (2311); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 11/04/2011

Event Type  malfunction  

Event Description

On (b)(4) 2011, the equipment distributor, medtronix medical supplies, (b)(4), was installing a new hl20 at (b)(6).The distributor reported that during the installation of the twin pump module tpm 20-330 twin roller pump (article number: (b)(4)) that the led switch on the right side of the tpm was defective.The distributor reported the event to the maquet service technician on (b)(4) 2011.Reference: (b)(4).

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary ag provides product failure investigation, analysis, and resolution for the device described in this report.The defective led was replaced.Reference: (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 CARDIOPULMOARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4280436
• MDR Text Key: 18634791
• Report Number: 8010762-2014-00539
• Device Sequence Number: 1
• Product Code: DPW
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: K984338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2011

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: Other
• Device Model Number: MCP00703323
• Device Catalogue Number: 70103.5075
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/09/2011
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2011
• Date Manufacturer Received: 11/09/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2010
• 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