MAUDE Adverse Event Report: DATASCOPE MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problems No Audible Alarm (1019); Occlusion Within Device (1423); Material Rupture (1546)

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

Event Date 10/18/2017

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.A supplemental report will be submitted when additional information is made available.

Event Description

Customer reported that on (b)(6) 2017 intra- aortic balloon pump (iabp) therapy was started and on (b)(6) 2017 at 3:30, blood was found by the nurse in the intra aortic balloon (iab) catheter tube (zeon).Thirty minutes later, balloon rupture was confirmed by ce and the iab was removed and therapy discontinued.Customer noted that there was excessive amount of blood and clots in the catheter tube, but no alarm was generated on the iabp.The iab that was in use (zeon) is not a getinge product.No death, injury or adverse event was reported.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and was able to confirm the inflow of blood into the unit.The fse replaced the blood detect tubing, condensation removal module assembly, pneumatic component luer and safety disk.Unrelated to the reported failure, the batteries were also replaced.The fse performed running test without incurring any problems.

Event Description

Customer reported that on (b)(6) 2017 intra- aortic balloon pump (iabp) therapy was started and on (b)(6) 2017 at 3:30, blood was found by the nurse in the intra aortic balloon (iab) catheter tube (zeon).30 minutes later, balloon rupture was confirmed by ce and the iab was removed and therapy discontinued.Customer noted that there was excessive amount of blood and clots in the catheter tube, but no alarm was generated on the iabp.The iab that was in use (zeon) is not a getinge product.No death, injury or adverse event was reported.

• Brand Name: CS100
• 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: 7014684
• MDR Text Key: 92766894
• Report Number: 2249723-2017-00766
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/26/2018

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: N/A
• Device Catalogue Number: 0998-00-3013-65
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 10/20/2017
• Initial Date FDA Received: 11/09/2017
• Supplement Dates Manufacturer Received: 01/18/2018
• Supplement Dates FDA Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2008
• 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