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

Catalog Number IAP-0500

Device Problems Pre Or Post-Pumping Problem (1477); Low Battery (2584)

Patient Problem No Patient Involvement (2645)

Event Date 03/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via a call from the biomed who stated that last week the field service agent (fsa) was in to do preventative maintenance on the pumps.They had one that had a battery that would not hold a charge and failed.This week the same unit has failed.It would not hold a charge and did not always turn on, even when plugged in.The clinical support specialist (css) told the biomed that she would have the fsa call him to discuss.The biomed thanked the css for my assistance.Per field service report received on (b)(6) 2016: symptom - power supply (p/s) not charging battery; battery sends 12.2 volts after charging overnight.Findings/action taken: could not reproduce symptom.Battery reads 13.2 volts on the screen and measures 13.5v at p/s.Replaced p/s as a pre-caution.Electrical safety test was performed.All functions, signals & voltages were checked.The unit checks ok.Software level: 2.24.

Manufacturer Narrative

(b)(4).Device evaluation: no parts or recorder strips were returned to the teleflex (b)(4) facility for evaluation.The pump was checked by the field service representative and no problem was found during the repair.The pump was charging the battery as normal.The power supply was replaced for a precautionary measure.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 review was not required.No functional issue was found with the pump.Conclusion: the reported complaint of "power supply not charging the battery" is unable to be confirmed.The field service representative could not reproduce the issue during the repair.The power supply was replaced for a precautionary measure.The cause of the reported complaint is undetermined.

Event Description

It was reported via a call from the biomed who stated that last week the field service agent (fsa) was in to do preventative maintenance on the pumps.They had one that had a battery that would not hold a charge and failed.This week the same unit has failed.It would not hold a charge and did not always turn on, even when plugged in.The clinical support specialist (css) told the biomed that she would have the fsa call him to discuss.The biomed thanked the css for my assistance.Per field service report received on (b)(6) 2016: symptom - power supply (p/s) not charging battery; battery sends 12.2 volts after charging overnight.Findings/action taken: could not reproduce symptom.Battery reads 13.2 volts on the screen and measures 13.5v at p/s.Replaced p/s as a pre-caution.Electrical safety test was performed.All functions, signals & voltages were checked.The unit checks ok.Software level: 2.24.

• Brand Name: AUTOCAT2 WAVE
• Type of Device: INTRA-AORTIC BALLOON PUMP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: kathryn myers ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5517014
• MDR Text Key: 40910452
• Report Number: 1219856-2016-00075
• 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,other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2016
• 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: 30801902051715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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