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

Model Number 0998-00-0800-53

Device Problem Device Contamination with Body Fluid (2317)

Patient Problems Thrombus (2101); Injury (2348)

Event Date 01/04/2021

Event Type  malfunction  

Manufacturer Narrative

There are many components blood soaked and damaged.Staff may not repair unit based upon repair costs.A supplemental report will be submitted if additional is provided.Device evaluated by manufacturer? not returned to manufacturer.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) had a reported blood back issue.I copied a note from the bedside rn who cared for the patient yesterday and witnessed the iabp malfunction.While the rn was in the room assessing the patient, he witnessed blood backing up into the helium line.Before the iabp started alarming he was assessing and troubleshooting and placed the pump on standby.He quickly got the necessary staff into the room to help.Drs.(b)(6) all saw patient at bedside when the event occurred and assumed the balloon had ruptured.Plans were made quickly for the patient to go to cath lab to replace iabp.Patient was sitting in bed, stable, with bipap on prior to the event.The patient was coughing violently about 10 minutes prior to the helium line filling with blood.The patient was immediately intubated and taken to the operating room within the hour for intra-aortic balloon(iab) replacement.Per the operating room team, found intra-aortic balloon(iab) intact, but the wire in the balloon was found to be broken.The pa and surgeon in the cath lab both mention in their op notes that there was a thrombus in the patient's axillary hemoshield graft.A thrombectomy was performed, and the iabp was exchanged.The exchange of the wire was not possible because it goes into the iab through the ruptured part inside the balloon.Then we opened the skin to take the insertion sheath, and then we passed a #6 fogarty catheter to perform the embolectomy.We could retrieve most of the clots.A separate report that will send to the report involve iab.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) had a reported blood back issue.I copied a note from the bedside rn who cared for the patient yesterday and witnessed the iabp malfunction.While the rn was in the room assessing the patient, he witnessed blood backing up into the helium line.Before the iabp started alarming he was assessing and troubleshooting and placed the pump on standby.He quickly got the necessary staff into the room to help.Drs.Sappington, lagazzi, and bianco all saw patient at bedside when the event occurred and assumed the balloon had ruptured.Plans were made quickly for the patient to go to cath lab to replace iabp.Patient was sitting in bed, stable, with bipap on prior to the event.The patient was coughing violently about 10 minutes prior to the helium line filling with blood.The patient was immediately intubated and taken to the operating room within the hour for intra-aortic balloon(iab) replacement.Per the operating room team, found intra-aortic balloon(iab) intact, but the wire in the balloon was found to be broken.The pa and surgeon in the cath lab both mention in their op notes that there was a thrombus in the patient's axillary hemoshield graft.A thrombectomy was performed, and the iabp was exchanged.The exchange of the wire was not possible because it goes into the iab through the ruptured part inside the balloon.Then we opened the skin to take the insertion sheath, and then we passed a #6 fogarty catheter to perform the embolectomy.Most of the clots were retrieved.Iab complaint created.

Manufacturer Narrative

The production device history record (dhr) for this iabp unit was reviewed and no non-conformances related to the reported event were noted.A getinge field service engineer (fse) reported onsite to assess the damage and create a service quote.No service completed on the iabp.The staff to decide to repair or purchase new.The unit is not cleared for clinical use.A supplemental will be submitted if new information is provided.

Event Description

N/a.

Manufacturer Narrative

It has been reported that the customer has scrapped the unit.Analysis of production: (3331/142) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109/142) the review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.Trend analysis: (4110/142) the overall 12 month product complaint trend data for the period feb 2020 through jan 2021 was reviewed.There were no triggers identified for the review period.

• Brand Name: CARDIOSAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: dorota wolpiuk ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 11224117
• MDR Text Key: 228489504
• Report Number: 2249723-2021-00137
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2016
• 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
• Treatment: #6 FOGARTY CATHETER.; UNKNOWN.; #6 FOGARTY CATHETER
• Patient Outcome(s): Other