MAUDE Adverse Event Report: DATASCOPE MAHWAH CS300 INTRA-AORTIC BALLOON PUMP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0998-00-3023-XX

Device Problems Loss of Power (1475); Pumping Stopped (1503); Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

On (b)(6)2017, it was reported by the customer that while in use on a patient the iabp exhibited error message electrical test fails code #50 (motor speed out of specification). Further, it was reported the iabp had shutdown/pump stopped. On (b)(6)2017, the customer reported to a maquet representative that the therapy could not be completed and is alleging the patient suffered an adverse event as a result of the iabp malfunction.

Manufacturer Narrative

On (b)(6) 2017 06:37 pm (gmt-5:00) added by (b)(6) (b)(4): the production device history record (dhr) for the iabp involved in the event was reviewed. There were no non conformances noted in the dhr related to the reported event. The company field service engineer (fse) evaluated the unit and reviewed the fault logs. The following was reported: the fse was able to confirm the event based on the review of the logs. Further, the pump assembly (part number (b)(4) was replaced and sent to the manufacturer for further evaluation. The pump assembly is still under investigation and the investigation results are pending.

Event Description

On (b)(6) 2017, it was reported by the customer that while in use on a patient the iabp exhibited error message electrical test fails code #50 (motor speed out of specification). Further, it was reported the iabp had shutdown/pump stopped. On (b)(6) 2017, the customer reported to a maquet representative that the therapy could not be completed and is alleging the patient suffered an adverse event as a result of the iabp malfunction.

Manufacturer Narrative

The replaced part/component, pump assembly (part number 0102-00-0001) was returned to the manufacturing facility for further evaluation. The pump failed testing, the reported failure of "electrical test fails code #50" was verified, and pump does not power up. The company representative disassembled the pump assembly and removed the vacuum and pump heads. The vacuum head internal parts were intact. The internal pressure head parts showed physical damage inside. The retaining screw holding the clamping disc was warped and the clamping disc wore through the head of the retaining screw. Metal filings inside the pump were also observed. The company representative replaced the retaining screw and the clamping disc of the pressure head, reassembled the pump assembly, and tested the pump to factory specifications. Specific actions for this failure mode are being managed and documented in the maquet corrective and preventive action (capa) system.

Event Description

On (b)(6), it was reported by the customer that while in use on a patient the iabp exhibited error message electrical test fails code #50 (motor speed out of specification). Further, it was reported the iabp had shutdown/pump stopped. On (b)(6) 2017, the customer reported to a maquet representative that the therapy could not be completed and is alleging the patient suffered an adverse event as a result of the iabp malfunction.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 6302691
• MDR Text Key: 104296317
• Report Number: 2249723-2017-00005
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 0998-00-3023-XX
• Other Device ID Number: SI190069C1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: YR
• Event Location: No Information
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 02/03/2017 Patient Sequence Number: 1