MAUDE Adverse Event Report: HOSPIRA, LTD SECNDRY SET 34IN NDEHP W/EXT HOOK; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 14230

Device Problem Free or Unrestricted Flow (2945)

Patient Problems Headache (1880); Chills (2191); Palpitations (2467)

Event Date 10/31/2016

Event Type  Injury  

Event Description

The customer reported that the patient was receiving an infusion of normal saline through a baxter tubing set and baxter pump when hospira¿s secondary set was primed for a campath infusion which was clamped and connected to the baxter tubing set.The customer further reported that though the set was clamped all the way down the medication still flowed through the tubing and the patient received the dose of campath over 10 minutes instead of the intended 2 hours.It was reported that the patient experienced a severe allergic reaction, palpitations, shakiness, chest tightness, tremors, cough, headache, chills and rigor and received 25 mg of demerol, steroids and benadryl.It was further reported that the patient was okay after the event and went home.Testing and investigation is complete.The actual device involved in the reported event was not returned for analysis.Probable cause could not be determined since no sample, pictures or videos are available for investigation.

Event Description

The customer reported that the patient was receiving an infusion of normal saline through a baxter tubing set and baxter pump when hospira¿s secondary set was primed for a campath infusion which was clamped and connected to the baxter tubing set.The customer further reported that though the set was clamped all the way down the medication still flowed through the tubing and the patient received the dose of campath over 10 minutes instead of the intended 2 hours.It was reported that the patient experienced a severe allergic reaction, palpitations, shakiness, chest tightness, tremors, cough, headache, chills and rigor and received 25 mg of demerol, steroids and (b)(4).It was further reported that the patient was okay after the event and went home.Testing and investigation is complete.The actual device involved in the reported event was not returned for analysis.Probable cause could not be determined since no sample, pictures or videos are available for investigation.Subsequent to the submission of the initial medical device report, additional information was received from the customer.The customer reported that no dripping was noted in the drip chamber when the secondary tubing was clamped.

• Brand Name: SECNDRY SET 34IN NDEHP W/EXT HOOK
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): HOSPIRA, LTD; 9613251; carretera sanchez km. 18 1/2; haina sancristobal ; DR
• Manufacturer (Section G): HOSPIRA, LTD; carretera sanchez km. 18 1/2; haina sancristobal ; DR
• Manufacturer Contact: roee lazebnik ; 600 n. field drive; bldg. h2-2e; lake forest, IL 60645-,USA ; 2242125740
• MDR Report Key: 6205506
• MDR Text Key: 63308391
• Report Number: 9613251-2016-00007
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787006268
• UDI-Public: (01)10887787006268
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 14230
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BAXTER PUMP AND TUBING SET, NS AND CAMPATH
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR