MAUDE Adverse Event Report: SUMMIT MEDICAL PRODUCTS, INC. AMBIT YELLOW PIB-PCA PUMP; ELECTRONIC INFUSION PUMPS & SYSTEMS

Model Number	220501Y AUS
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is in-progress.All information reasonably known as of 30 sep 2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical inc.Complaint database, and identified as complaint (b)(4).Device not returned.
Event or Problem Description
Fill volume: unknown.Flow rate: 10ml bolus in pib setting.Procedure: nerve block.Cathplace: unknown.Infusion start time: unknown.Infusion stop time: unknown.It was reported that , "the doctor was demonstrating the pump to nursing staff.The doctor initiated a 10ml bolus and he believes the pump continued to run beyond the expected period.The doctor removed the pump from the patient and believes the pump ended up delivering 20mls.Doctor informs there was no adverse impact on the patient." the distributor picked up the pump and stated the pump prescription and history readings state it is set up for programmable intermittent bolus (pib) for 10mls every 3 hours and that the pump has run for 7 hours 38 minutes and delivered 20mls.The distributor let the pump run to its next bolus delivery point and measured the output using a manual measuring device; the pump accurately delivered 10mls every 3 hours.The pump was infusing 0.2% ropivacaine.
Additional Manufacturer Narrative
The device history record for lot e932901 was reviewed and the product was produced according to product specifications.The actual complaint product was returned for evaluation.The reported failure of incorrect flow/fast flow could not be confirmed as the pump operated with no failures and ran correctly.Root cause was determined to be use error.All information reasonably known as of 04 dec 2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.
Event or Problem Description
Additional information received 20-nov-2020 indicated the pump was attached to a 200ml bag of ropivacaine 0.2%.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 24 oct 2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.

• Brand Name: AMBIT YELLOW PIB-PCA PUMP
• Common Device Name: ELECTRONIC INFUSION PUMPS & SYSTEMS
• Manufacturer (Section D): SUMMIT MEDICAL PRODUCTS, INC.; 504 west 8360 south; sandy UT 84070
• MDR Report Key: 10607529
• Report Number: 1722214-2020-00004
• Device Sequence Number: 16844796
• Product Code: FRN
• UDI-Device Identifier: 00857595005695
• UDI-Public: 00857595005695
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K162165
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2020

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
• Operator of Device: Health Professional
• Device Model Number: 220501Y AUS
• Device Catalogue Number: 220501Y
• Device Lot Number: E932901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/07/2020
• Supplement Date Received by Manufacturer: 10/07/2020; 11/16/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 10/27/2020; 12/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.2% ROPIVACAINE; 0.2% ROPIVACAINE
• Patient Age: 64 YR
• Patient Weight: 59