MAUDE Adverse Event Report: ARROW INTL., INC. IAB : 8 FR- 40 CC FOS; INTRA-AORTIC BALLOON FIBEROPTIC SYST

Catalog Number IAB-05840-LWS

Device Problem Failure to Select Signal (1582)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 02/20/2015

Event Type  malfunction  

Event Description

It was reported at 3:42pm est via a hotline call from the rn in the cvicu (cardiovascular intensive care unit) that she was called to the operating room (or) to bring a pump console for a patient who was having an intra-aortic balloon (iab) inserted intraoperative.Indication for use: intra-op cabg (coronary artery bypass grafting).When the rn arrived in the operation room the patient already had a 40cc fox (fiberoptix sensor) iab inserted in the femoral artery via a sheath.The rn was handed the fos connections and the helium driveline tubing to attach to the console.According to the rn, after the connections were made and she pressed the on button, she received purge failure alarms and was unable to initiate pumping.The clinical support specialist (css) and the rn discussed that there was no trigger on the pump which would lead to purge failure alarms.The rn said the patient did have an arterial pressure displayed on the table monitor.The rn said the fos indicator was lit, but the fos icon was black (fos iab not corrected).Fos status codes were ll (low light) and pl (fos is measuring outside of pressure range).The css asked the rn to remove the fos connector from the pump and to reinsert.At this time no tones were heard when the connection was made, but the surgeon had already begun to remove the iab from the patient.Per the rn the md said he decided to replace the iab with another one.The css waited on the phone while the second iab was inserted (same insertion site).Again the iab was inserted prior to the fos connection being made.The rn is aware that a map cal will need to be performed after insertion.The rn made the fos connections, the tones were heard and the ap (arterial pressure) waveform was on the console.Pumping was initiated and the rn needed to end the call.Per the rn the iab that was removed will be sent to the ccl.At 4:10pm est the css spoke to a person in the ccl who stated that the outcome of the patient is patient continues on iabp.

Manufacturer Narrative

Qn# (b)(4).

• Brand Name: IAB : 8 FR- 40 CC FOS
• Type of Device: INTRA-AORTIC BALLOON FIBEROPTIC SYST
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 9 plymouth st.; everett MA 02149
• Manufacturer Contact: kathryn myers, ra ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 4605790
• MDR Text Key: 5466744
• Report Number: 1219856-2015-00051
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F14M0001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1