MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-05840-LWS

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546); Device Contamination with Body Fluid (2317)

Patient Problems Low Blood Pressure/ Hypotension (1914); Hypoxia (1918)

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: n levels in the 80's.Medications infusing: heparin, epinephrine, dopamine, amiodarone, vasopressin, versed and fentanyl.Qn# (b)(4).

Event Description

It was reported by the rn that they have a critical patient with an intra-aortic balloon (iab) and the rn called the clinical support specialist (css) to discuss rust flecks noted in the driveline tubing.It was reported that the blood was first noted in the driveline tubing with the night shift nurse.The night shift rn had reported 2 more helium loss alarms.The physicians were notified and came to the bedside and opted to watch it over time as there were no more alarms and the [patient was not yet therapeutic on his heparin].The day shift rn has had no alarms her entire shift.The css explained to the rn the immediate need to remove the iab and the concern for entrapment.As a result, the iab was eventually removed without issue.It was also reported that blood was seen in the quick connect and also in the condensation trap.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Concomitant medical products: n levels in the 80's.Medications infusing: heparin, epinephrine, dopamine, amiodarone, vasopressin, versed and fentanyl.(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iab blood in helium pathway is not able to be confirmed.The root cause of the complaint is undetermined.If the product is returned at a later date, a full investigation of the sample will be completed.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported by the rn that they have a critical patient with an intra-aortic balloon (iab) and the rn called the clinical support specialist (css) to discuss rust flecks noted in the driveline tubing.It was reported that the blood was first noted in the driveline tubing with the night shift nurse.The night shift rn had reported 2 more helium loss alarms.The physicians were notified and came to the bedside and opted to watch it over time as there were no more alarms and the [patient was not yet therapeutic on his heparin].The day shift rn has had no alarms her entire shift.The css explained to the rn the immediate need to remove the iab and the concern for entrapment.As a result, the iab was eventually removed without issue.It was also reported that blood was seen in the quick connect and also in the condensation trap.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

D11: n levels in the 80's.Medications infusing: heparin, epinephrine, dopamine, amiodarone, vasopressin, versed and fentanyl.(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iab blood in helium pathway is not able to be confirmed.The root cause of the complaint is undetermined.If the product is returned at a later date, a full investigation of the sample will be completed.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.Other remarks: this complaint has been reopened to investigate the device that was returned to teleflex for investigation.The reported complaint of iab blood in helium pathway is confirmed.A puncture to the bladder, consistent with contact from the broken fiber, was found near the distal tip of the iab which allowed blood to enter the helium pathway.No other leaks were detected during functional testing.The root cause of the broken fiber is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported by the rn that they have a critical patient with an intra-aortic balloon (iab) and the rn called the clinical support specialist (css) to discuss rust flecks noted in the driveline tubing.It was reported that the blood was first noted in the driveline tubing with the night shift nurse.The night shift rn had reported 2 more helium loss alarms.The physicians were notified and came to the bedside and opted to watch it over time as there were no more alarms and the [patient was not yet therapeutic on his heparin].The day shift rn has had no alarms her entire shift.The css explained to the rn the immediate need to remove the iab and the concern for entrapment.As a result, the iab was eventually removed without issue.It was also reported that blood was seen in the quick connect and also in the condensation trap.There was no report of patient complications, serious injury or death.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8793881
• MDR Text Key: 151153437
• Report Number: 3010532612-2019-00216
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F17H0041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Date Manufacturer Received: 11/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VENTILATOR SUPPORT AND PARALYZED TO MAINTAIN OXYGE; VENTILATOR SUPPORT AND PARALYZED TO MAINTAIN OXYGE; VENTILATOR SUPPORT AND PARALYZED TO MAINTAIN OXYGE; VENTILATOR SUPPORT AND PARALYZED TO MAINTAIN OXYGE
• Patient Age: 62 YR
• Patient Weight: 111