MAUDE Adverse Event Report: ARROW INTL., INC. IAB : 7.5 FR - 40 CC; INTRA-AORTIC BALLOON PUMP PRODUCTS

Catalog Number IAB-06840-U

Device Problem Component Incompatible (1108)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2014

Event Type  malfunction  

Event Description

It was reported that the event occurred after the user had inserted an intra-aortic balloon (iab-06840-u) without issue and only after the pt was returned to the ward.It was observed that inside the packaging of the kit was "white" pump tubing instead of "blue" pump tubing.Add'l info received on (b)(4) 2014 stated that they noticed the wrong white tubing as soon as the pt returned to the ward; they then replaced it with their spare blue tubing.Therapy continued normally.No alarms occurred; no pump strips are available for review.There was no report of pt death, complications or injury.No medical/surgical intervention was required.No delay or interruption in therapy was noted.The pt outcome is stable.It was noted that the arrow autocat2 wave intra-aortic balloon pump, serial number (b)(4) was used during this event.

Manufacturer Narrative

(b)(4).Device will not be returned for eval.

• Brand Name: IAB : 7.5 FR - 40 CC
• Type of Device: INTRA-AORTIC BALLOON PUMP PRODUCTS
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 9 plymouth st.; everett MA 02149
• Manufacturer Contact: kathryn myers, reg. assoc. ; 2400 bernville rd.; reading, PA 19605 ; 6103780131
• MDR Report Key: 4088182
• MDR Text Key: 20294119
• Report Number: 1219856-2014-00150
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/31/2014

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 Catalogue Number: IAB-06840-U
• Device Lot Number: 18FL3M0021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2014
• Initial Date FDA Received: 08/01/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1