MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD ALARIS PUMP; INTRAVASCULAR ADMINISTRATION SET

Catalog Number UNKNOWN

Device Problem Free or Unrestricted Flow (2945)

Patient Problem Overdose (1988)

Event Date 12/31/2020

Event Type  Injury  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that the unspecified bd alaris¿ pump had unregulated flow during use and the "entire bag (~3/4 of a 25000u bag of heparin)" was infused when it was not clamped.As a result, a "stat aptt/antixa" was obtained and the patient received 50 mg of protamine pre-emptively.The following information was provided by the initial reporter: "the patient was on heparin gtt for a provoked left basilic vein thrombus and was being transitioned to apixaban.Rn stopped heparin and forgot to clamp it when removing from the pump and the entire bag (~3/4 of a 25000u bag of heparin) was infused into patient.A stat aptt/antixa was obtained and pharmd gave 50mg protamine pre-emptively.".

Manufacturer Narrative

H6: investigation: no product or photo was returned by the customer.It was reported that the rn stopped heparin and forgot to clamp it when removing from the pump and the entire bag (3/4 of a 25000u bag of heparin) was infused into patient.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a model or lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text : see h10.

Event Description

It was reported that the unspecified bd alaris¿ pump had unregulated flow during use and the "entire bag (3/4 of a 25000u bag of heparin)" was infused when it was not clamped.As a result, a "stat aptt/antixa" was obtained and the patient received 50 mg of protamine pre-emptively.The following information was provided by the initial reporter: "the patient was on heparin gtt for a provoked left basilic vein thrombus and was being transitioned to apixaban.Rn stopped heparin and forgot to clamp it when removing from the pump and the entire bag (3/4 of a 25000u bag of heparin) was infused into patient.A stat aptt/antixa was obtained and pharmd gave 50mg protamine pre-emptively.".

• Brand Name: UNSPECIFIED BD ALARIS PUMP
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11270400
• MDR Text Key: 230040163
• Report Number: 2243072-2021-00200
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 02/02/2021
• Supplement Dates Manufacturer Received: 02/04/2021
• Supplement Dates FDA Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention