MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HL20 TWIN PUMP

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2014

Event Type  malfunction  

Event Description

It was reported that during surgery, the cardioplegia slave pump (on the twin roller pump) stopped with the error message safety-s.No reported patient effect.No additional information was provided.(b)(4).

Manufacturer Narrative

The safety-s error refers to a failure regarding a recurring deviation between the measured and the set value of pump speed of at least 10%.Example: the pump speed is set with 1000 rounds per minutes (rpm) and the actual speed is measured on the pump head with greater than 1100 rpm.In order to protect the pump from excessive pump speed, an automatic pump stop is generated together with the safety-s error.In order to restart the pump, the user has to follow the instruction is the user manual.A supplemental medwatch will be submitted when additional information becomes available.

Manufacturer Narrative

Unable to confirm the failure due to not getting information from the customer.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.

Event Description

Additional information: reference: (b)(4).

• Brand Name: MAQUET HL20 TWIN PUMP
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4491482
• MDR Text Key: 5332832
• Report Number: 8010762-2015-00053
• Device Sequence Number: 1
• Product Code: DPW
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: K984338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,company repres
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other