MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAP-0500

Device Problem Low Battery (2584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via field service report l612180 that the pump had a short battery run time while on a patient.Additional information received from the field service agent stated the pump seemed to run ok in battery with the battery still strong at 22 minutes of run time.At 24 minutes the pump began to die quickly.At 25 minutes of operation, the 20 minutes left alarm came on and the pump shut down at the time.The pump was switched out with no harm to the patient.The fse replaced the defective battery.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of "short battery run time" is not confirmed.Although, the root cause of the reported complaint remains undetermined the power supply passed functional testing.The complaint will be monitored for developing trends.Per operator's manual "the battery should be maintained at full charge whenever possible.Arrow international recommends that the autocat2 series iabp be kept plugged into a proper ac receptacle whenever possible including time when the unit is in storage or not in use.The power indicator will illuminate when ac power is present.The batteries should not be stored in a discharged state." a device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.No further action required.

Event Description

It was reported via field service report l612180 that the pump had a short battery run time while on a patient.Additional information received from the field service agent stated the pump seemed to run ok in battery with the battery still strong at 22 minutes of run time.At 24 minutes the pump began to die quickly.At 25 minutes of operation, the 20 minutes left alarm came on and the pump shut down at the time.The pump was switched out with no harm to the patient.The fse replaced the defective battery.

• Brand Name: AUTOCAT2 WAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 6803393
• MDR Text Key: 83046354
• Report Number: 1219856-2017-00183
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0500
• Other Device ID Number: 00801902051714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1