MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HCU30 DEVICE; HCU30 200V-240V

Model Number 70103.4642

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2013

Event Type  malfunction  

Event Description

It was reported that a hcu 30 device had low flow on the cardioplegia side.No pt effect was reported.Reference: (b)(4).

Manufacturer Narrative

(b)(4).The device was investigated, repaired and returned to the service by a maquet field service technician.The defective cardioplegia pump is currently under investigation.A supplemental medwatch will be submitted when additional info becomes available.

• Brand Name: MAQUET HCU30 DEVICE
• Type of Device: HCU30 200V-240V
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strabe 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: janice pevide ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3802656
• MDR Text Key: 19722100
• Report Number: 8010762-2014-00076
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K031544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/25/2014,07/22/2013

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: 70103.4642
• Device Catalogue Number: 70103.4642
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/18/2014
• Device Age: 18 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/22/2013
• Initial Date FDA Received: 02/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• 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