MAUDE Adverse Event Report: DATASCOPE CORP. TCH 1/4" PACK W QIDP, RF & AV; CARDIOPULMONARY DEVICE

Model Number BEQ-TOP 5909

Device Problem Malfunction (2409)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2014

Event Type  malfunction  

Event Description

A pt was on single ventricle circulatory support utilizing hl20 and rotaflow.The rotaflow was in art mode and the inlet pressure was monitored on pressure 3 allowing for servo regulation.The clinician observed that the rotaflow/hl20 responded to an inlet pressure in the servo regulation range with a soft alarm and slowing rpms.The rpms continued to ramp down to the point that they reached zero.This situation was interpreted by the clinician as hypovolemia or cannulae misplacement.After attempts to correct the situation, the clinician chose to provide manual circulatory support.It was determined that a clot had developed in the pressure line at the point where the pressure tubing connects to the circuit.It is believed that the clot "fixed" the pressure at a point within the servo regulation range.Despite the release or reduction in pressure within the circuit, it was not reflected in the pressure line, and therefore, did not transmit to the pressure transducer and hl20 controller.Therefore the hl20 continued to interpret a pressure requiring servo regulation intervention.No adverse consequences were reported for this event.

Manufacturer Narrative

The device was not returned and no pictures or tubing pack lot info was provided.A root cause could not be identified or the complaint confirmed as no device was available for testing.Additionally, since no pack lot info was provided, device history records could not be reviewed.If additional info is received or the product is returned, a supplemental report will be submitted.(b)(4).

• Brand Name: TCH 1/4" PACK W QIDP, RF & AV
• Type of Device: CARDIOPULMONARY DEVICE
• Manufacturer (Section D): DATASCOPE CORP.; fairfield NJ
• Manufacturer Contact: jason de sousa ; 15 law dr.; fairfield, NJ 07004 ; 9737097256
• MDR Report Key: 3899651
• MDR Text Key: 4428036
• Report Number: 2248146-2014-00080
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-TOP 5909
• Device Catalogue Number: 701064992
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 4 MO
• Patient Weight: 6