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

Catalog Number 0998-00-0800-XX

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/28/2017

Event Type  malfunction  

Manufacturer Narrative

09/12/2017 12:47 pm (gmt-4:00) added by (b)(4) (pid-(b)(4)): the updated and corrected fields previously reported should read as: corrected field: 08/02/2017 (the date entered in the initial mdr was incorrect, and should have been (b)(4)2017). 09/08/2017 03:32 pm (gmt-4:00) added by (b)(4)(pid-(b)(4)): a getinge company representative stated that the hospital ordered the parts & their own in-house medical physics repaired & replaced the parts. Details of the repair and parts replaced were not provided.

Event Description

The customer reported that the intra-aortic balloon pump (iabp) alarmed and stopped inflating when repositioning the patient. When investigating the alarm and checking the tubing, there was clearly blood visible in the tubing connecting intra-aortic balloon pump (iab) catheter to iabp machine. The medical staff was called, tubing was clamped and decision was made to remove iabp and sheath as the customer was unable to remove catheter alone. The catheter, tubing and machine were then sent to medical physics for investigation. This event occurred while in use on a patient. No adverse event was reported. It was later reported that the alarm that occurred during the event was "standby one minute".

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was unable to be reviewed as we were not able to obtain the serial number for the iabp associated with this complaint. Additional information has been requested from the maquet/getinge business unit. If the information is provided, it will be reported accordingly.

Event Description

The customer reported that the intra-aortic balloon pump (iabp) alarmed and stopped inflating when repositioning the patient. When investigating the alarm and checking the tubing, there was clearly blood visible in the tubing connecting intra-aortic balloon pump (iab) catheter to iabp machine. The medical staff was called, tubing was clamped and decision was made to remove iabp and sheath as the customer was unable to remove catheter alone. The catheter, tubing and machine were then sent to medical physics for investigation. This event occurred while in use on a patient. No adverse event was reported.

• Brand Name: CARDIOSAVE
• 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: 6812001
• MDR Text Key: 104180805
• Report Number: 2249723-2017-00320
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/12/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 0998-00-0800-XX
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: YR
• Event Location: No Information
• Date Manufacturer Received: 08/23/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse