MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG SINGLE ROLLER PUMP MODULE

Model Number MCP0.0703309

Device Problems Device Displays Incorrect Message (2591); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/19/2015

Event Type  malfunction  

Event Description

It was reported that one of the rpm 20's ran at full speed momentarily.This happened just after the case while emptying the vent lines.No reported patient effect.(b)(4).

Manufacturer Narrative

A supplemental medwatch will be submitted when additional information becomes available.(b)(4).Both products are components of the hl20 integrated perfusion system cleared under 51(k) k943803.

Manufacturer Narrative

Field safety technician has been investigated and found failure reported.He added the grounding and no further instances since then.Thus the failure could be confirmed.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.

• Brand Name: SINGLE ROLLER PUMP MODULE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4562023
• MDR Text Key: 5457747
• Report Number: 8010762-2015-00118
• Device Sequence Number: 1
• Product Code: DPW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP0.0703309
• Device Catalogue Number: MCP0.0703309
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2010
• 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): Other